An interventional study of Pulmonary vein isolation in Persistent Atrial Fibrillation, sponsored by Mitera Hospital. Not yet recruiting at 10 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Mitera Hospital · Not applicable, Interventional, and Treatment
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Among 77 studies in Atrial Fibrillation with a site in Greece — 11 open to participants now, 17 under way, 3 of them phase 3. Atrial Fibrillation · Greece.
Among the 77 studies in Atrial Fibrillation with a site in Greece, this one is the 32nd largest by planned enrollment of the 46 interventional ones that give a count, is the only one that started in 2027, is one of 20 with no phase, reaches primary completion later than 16 of the 16 other live ones, and was the 77th registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.
Browse Atrial Fibrillation studies →11 of the 77 studies in Atrial Fibrillation with a site in Greece are open now. Recruiting first, the newest first:
Mitera Hospital · Sites in Greece, Croatia, Czechia and 5 more countries
Ages 18+
University Hospital of Patras · Sites in Greece
Ages 18+
McMaster University · Sites in Greece, United States, Belgium and 1 more country
Ages 18+
Medtronic Cardiac Ablation Solutions · Sites in Greece, Australia, Belgium and 13 more countries
Ages 18+
National and Kapodistrian University of Athens · Sites in Greece
Ages 40–100
A study can be open while its sites in Greece have not opened yet or have stopped. Only those recruiting at a site in Greece →
Of the 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
77 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 250 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Median enrollment 780 across the 46 interventional studies, 524 across the 31 observational. Of the 45 that completed or were terminated, 19 (42%) have results posted.
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35 of 77 have an industry lead sponsor. The 10 most frequent:
Mitera Hospital is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Mitera Hospital has 2 studies filed under Atrial Fibrillation — fewer than ten, so there is no comparison to draw.
4 of the studies in Atrial Fibrillation with a site in Greece that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05757869Phase 3Janssen Research & Development, LLCA Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation | 2026-12-08 |
| NCT05494034National and Kapodistrian University of AthensYield of Implantable Cardiac Monitoring Device in Patients With Acute Ischemic Stroke. | 2027-01-01 |
| NCT06656884Boston Scientific CorporationFARAPULSE Workflow Assessment Registry | 2027-02-15 |
| NCT06808217Boston Scientific CorporationA Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation | 2027-04-01 |
Add all 4 to your calendar (.ics) → With an account.
Among the 77 studies in Atrial Fibrillation with a site in Greece, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
LANCE-AF is a prospective, multicenter, multinational, randomized, non-inferiority trial comparing two pulsed-field ablation catheter technologies-the Sphere-9 lattice-tip catheter and the FARAPULSE pentaspline catheter-in patients with symptomatic persistent atrial fibrillation.
In both treatment groups, atrial fibrillation ablation will be restricted to pulmonary vein isolation. Empirical left atrial substrate modification will not be permitted. An insertable cardiac rhythm monitor will be implanted during the index procedure to provide continuous rhythm monitoring for 12 months.
The primary objective is to determine whether ablation using the Sphere-9 catheter is non-inferior to ablation using the FARAPULSE catheter with respect to acute pulmonary vein isolation and freedom from treatment failure through 12 months. Secondary objectives include comparisons of procedural safety, postablation atrial arrhythmia burden, longest atrial arrhythmia episode, quality of life, and procedural efficiency.
Pulsed-field ablation is increasingly used for pulmonary vein isolation in patients with atrial fibrillation. However, the comparative efficacy, safety, and procedural efficiency of the Sphere-9 lattice-tip catheter and the FARAPULSE pentaspline catheter have not been established in patients with persistent atrial fibrillation. Furthermore, outcomes following a pulmonary-vein-isolation-only strategy in this population have not been adequately evaluated using continuous rhythm monitoring.
LANCE-AF is a prospective, multicenter, multinational, randomized, non-inferiority trial enrolling patients with symptomatic persistent atrial fibrillation. Eligible participants must have continuous atrial fibrillation lasting more than 7 but less than 365 days. Participants will be randomized in a 1:1 ratio to pulmonary vein isolation using either the Sphere-9 lattice-tip catheter or the FARAPULSE pentaspline catheter.
All participants will undergo pulmonary vein isolation as the sole permitted atrial fibrillation ablation lesion set. Empirical left atrial substrate modification will not be permitted. Participants presenting in atrial fibrillation or another non-sinus rhythm will undergo cardioversion to sinus rhythm before ablation. Acute procedural success will be confirmed by demonstration of entrance block in all treated pulmonary veins at the end of the procedure. Cavotricuspid isthmus ablation is the only permitted non-pulmonary-vein lesion set and may be performed only in participants with documented typical atrial flutter. Catheter use for cavotricuspid isthmus ablation will follow the treatment-group-specific requirements defined in the protocol.
An insertable cardiac rhythm monitor will be implanted during the index procedure and will provide continuous rhythm monitoring throughout the study, with a 2-month postablation blanking period.
Participants will be followed for 12 months after the index ablation procedure, with continuous rhythm monitoring provided by the insertable cardiac monitor. Scheduled remote assessments will be performed at 30 days, at the end of the 2-month blanking period, and at 6 months. An in-person assessment will be performed at 12 months. Unscheduled assessments will be performed as clinically indicated.
The primary endpoint combines acute ablation success with freedom from treatment failure through 12 months. Treatment failure is defined as the occurrence of any of the following: insertable-cardiac-monitor-documented atrial fibrillation, atrial flutter, or atrial tachycardia lasting at least 6 minutes; electrical or pharmacological cardioversion for an atrial arrhythmia; repeat atrial ablation; or protocol-defined use of a Class I or Class III antiarrhythmic drug. These events are assessed after the 2-month blanking period, except that any amiodarone use after the index ablation, including during the blanking period, constitutes treatment failure.
Secondary outcomes include a composite of prespecified device- and procedure-related adverse events, postablation atrial fibrillation/atrial flutter/atrial tachycardia burden, the proportion of participants with an atrial arrhythmia burden below 0.1%, the duration of the longest atrial arrhythmia episode, time to first atrial arrhythmia episode, changes in quality of life assessed using the AFEQT and EQ-5D-5L questionnaires, total procedure time, left atrial dwell time, and fluoroscopy time and dose.
All insertable-cardiac-monitor-flagged episodes contributing to the efficacy endpoints will be reviewed by two independent adjudicators blinded to treatment assignment and catheter type. Disagreements will be referred to a third blinded adjudicator, with the majority determination considered final. Prespecified safety events will be reviewed by an independent Clinical Events Committee. An independent Data and Safety Monitoring Board will provide external safety oversight. The primary non-inferiority analysis will be performed in both the Full Analysis Set and Per-Protocol populations using a non-inferiority margin of 10 percentage points.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Anatomical and procedural exclusions
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the Sphere-9 arm, only pulsed field applications will be used for point-by-point antral pulmonary vein isolation. Deployment of linear lesions along the right and left pulmonary vein carinas is strongly recommended in the absence of a common ostium, ensuring balanced anatomical lesion sets equivalent to the intrinsic carinal coverage achieved with the pentaspline catheter during superior and inferior vein deployments. To aim for contiguous lesions, an inter-lesion distance of 5 mm should be argeted and tissue contact should be confirmed using impedence measures and real time monitoring of the temperature rise in the appropriate graph. In patients with documented typical atrial flutter, cavotricuspid isthmus ablation will be performed with the Sphere-9 catheter using radiofrequency energy only.
Procedure: Pulmonary vein isolation
In the Farapulse arm, procedural guidance with three-dimensional electroanatomical mapping using OPAL HDx system with the FARAVIEW module is mandatory. Pulmonary vein isolation will be performed with a minimum of 8 applications per pulmonary vein (4 "basket"-configuration and 4 "flower"-configuration applications). Additional applications may be delivered at operator discretion to achieve entrance block and will be systematically recorded. In patients with documented typical atrial flutter, operators may perform cavotricuspid isthmus ablation using either the pentaspline catheter with standard precautions, including prophylactic nitroglycerin per institutional protocol, or a standard commercially approved focal ablation catheter, at operator discretion. Use of the Sphere-9 catheter in the Farapulse arm is prohibited.
Procedure: Pulmonary vein isolation
The use of general anesthesia is mandatory for all study procedures. All patients presenting in a non-sinus rhythm will be cardioverted to sinus rhythm. Pulmonary vein isolation constitutes the sole permitted ablation lesion set for atrial fibrillation; empirical left atrial substrate modification is not allowed. Cavotricuspid isthmus ablation will be the only non-pulmonary vein isolation ablation permitted and must be strictly confined to patients with documented typical atrial flutter.
Number of participants with acute ablation success and freedom from treatment failure.
The primary endpoint will be the number of participants with acute ablation success (achievement of pulmonary vein isolation, confirmed by entrance block in all treated veins) and freedom from treatment failure through 12 months. Treatment failure is defined as the first occurrence of any of the following, assessed from the end of the 2-month blanking period onward, except for amiodarone use, which is assessed from the time of the index ablation: 1. Atrial fibrillation/atrial flutter/atrial tachycardia recurrence lasting ≥ 6 minutes, as documented by the implantable loop recorder 2. Cardioversion (electrical or pharmacological) for atrial fibrillation/atrial flutter/atrial tachycardia 3. Repeat ablation for atrial fibrillation/atrial flutter/atrial tachycardia 4. Use of a Class I or Class III antiarrhythmic drug after the blanking period, or any amiodarone use at any time after the index ablation, including during the blanking period
Time frame: From the index procedure to the end of the follow-up at 12 months.
Number of participants with device- and procedure-related complications
Number of participants experiencing at least on of the following pre-specified acute and chronic device- and procedure-related adverse events, per the recent AFib-ARC recommendations: stroke, transient ischemic attack, systemic embolism, coronary spasm, myocardial infarction, cardiac tamponade, esophageal complications (atrio-esophageal and esophago-pericardial fistula or perforation), pulmonary vein stenosis, phrenic nerve injury with diaphragmatic paralysis persisting \> 6 months, vagal nerve injury, acute kidney injury, major bleeding, iatrogenic interatrial septal defect requiring closure, pericarditis, heart failure/pulmonary edema, and any device- or procedure-related death.
Time frame: From the index procedure up to 30 days post intervention.
Percentage of monitored time spent in atrial fibrillation/atrial flutter/atrial tachycardia
Atrial arrhythmia burden will be calculated from insertable cardiac monitor data as the total duration of adjudicated atrial fibrillation/atrial flutter/atrial tachycardia episodes divided by the total analyzable monitoring time, expressed as a percentage. Burden will be calculated from the end of the 2-month blanking period until the earliest of 12 months, cardioversion, repeat ablation, or protocol-defined antiarrhythmic drug use and through the full 12-month follow-up period in a complementary uncensored analysis.
Time frame: From the end of the 2-month blanking period through 12 months after ablation.
Number of participants with an atrial fibrillation/atrial flutter/atrial tachycardia burden below 0.1%
Number of participants with insertable cardiac monitor-documented atrial fibrillation/atrial flutter/atrial tachycardia burden below 0.1%. Burden is defined as the total duration of adjudicated atrial arrhythmia episodes divided by the total analyzable monitoring time. In the primary analysis, participants undergoing cardioversion, repeat ablation, or protocol-defined antiarrhythmic drug treatment before 12 months will be classified as not achieving an arrhythmia burden below 0.1%.
Time frame: From the end of the 2-month blanking period through 12 months after ablation.
Duration of the longest postablation atrial fibrillation/atrial flutter/atrial tachycardia episode
Duration of the longest adjudicated atrial fibrillation/atrial flutter/atrial tachycardia episode recorded by the insertable cardiac monitor. The observation period will be censored at the first rhythm-altering intervention, defined as cardioversion, repeat ablation, or protocol-defined antiarrhythmic drug use.
Time frame: From the end of the 2-month blanking period until the earliest rhythm-altering intervention or 12 months after ablation.
Change from baseline in the EQ-5D-5L utility index at 12 months
Change from baseline to 12 months in health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire. Responses will be converted to a utility index using the prespecified applicable value set. Higher utility values indicate better health status. Change will be calculated as the 12-month value minus the baseline value; a positive change indicates improvement.
Time frame: Baseline and 12 months after ablation.
Change from baseline in the Atrial Fibrillation Effect on Quality-of-Life Total Score at 12 Months
Change from baseline to 12 months in atrial fibrillation-specific quality of life measured using the Atrial Fibrillation Effect on Quality-of-Life questionnaire. The total score ranges from 0 to 100, with higher scores indicating better quality of life and fewer atrial fibrillation-related limitations. Change will be calculated as the 12-month score minus the baseline score; a positive change indicates improvement.
Time frame: Baseline and 12 months after ablation.
Total duration of the index ablation procedure
Total duration of the index atrial fibrillation ablation procedure. Time required for implantation of the insertable cardiac monitor will not be included in the total procedure time.
Time frame: During the index ablation procedure
Left atrial catheter dwell time
Total time that the procedural catheter remains within the left atrium during the index atrial fibrillation ablation procedure.
Time frame: During the index ablation procedure.
Total fluoroscopy time
Total duration of fluoroscopy used during the index atrial fibrillation ablation procedure.
Time frame: During the index ablation procedure.
Total fluoroscopy radiation dose
Total radiation dose delivered during the index atrial fibrillation ablation procedure.
Time frame: During the index ablation procedure.
Time to first atrial fibrillation/atrial flutter/atrial tachycardia episode lasting at least 1 hour
Time from the end of the 2-month blanking period to the first insertable-cardiac-monitor-documented and adjudicated atrial fibrillation/atrial flutter/atrial tachycardia episode lasting at least 1 hour.
Time frame: From the end of the 2-month blanking period through 12 months after ablation
Time to first atrial fibrillation/atrial flutter/atrial tachycardia episode lasting at least 6 hours
Time from the end of the 2-month blanking period to the first insertable-cardiac-monitor-documented and adjudicated atrial fibrillation/atrial flutter/atrial tachycardia episode lasting at least 6 hours.
Time frame: From the end of the 2-month blanking period through 12 months after ablation
Time to first atrial fibrillation/atrial flutter/atrial tachycardia episode lasting at least 1 day
Time from the end of the 2-month blanking period to the first insertable-cardiac-monitor-documented and adjudicated atrial fibrillation/atrial flutter/atrial tachycardia episode lasting at least 1 day.
Time frame: From the end of the 2-month blanking period through 12 months after ablation
Time to first atrial fibrillation/atrial flutter/atrial tachycardia episode lasting at least 7 days
Time from the end of the 2-month blanking period to the first insertable-cardiac-monitor-documented and adjudicated atrial fibrillation/atrial flutter/atrial tachycardia episode lasting at least 7 days.
Time frame: From the end of the 2-month blanking period through 12 months after ablation
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
Start is estimated for Mar 2027; primary completion for Mar 2030, 36 months later.
Of 795 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 36 months is close to that.
Counting every sponsor, half of 1,050 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Mitera Hospital