An observational study in Atrial Fibrillation and Catheter Ablation, sponsored by Clinica Mediterranea. Recruiting at 9 sites in 3 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Clinica Mediterranea · Observational
Among 252 studies in Atrial Fibrillation with a site in Italy — 44 open to participants now, 64 under way, 2 of them phase 3. Atrial Fibrillation · Italy.
Among the 252 studies in Atrial Fibrillation with a site in Italy, this one is the 33rd largest by planned enrollment of the 95 observational ones, is one of 18 that started in 2023, is one of 95 observational ones, reaches primary completion later than 25 of the 63 other live ones, and was the 192nd registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 850 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →44 of the 252 studies in Atrial Fibrillation with a site in Italy are open now, in 12 countries. Each count lists the studies.
Of the 612 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 44 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes.
The full table on the hub →252 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 18 started in 2023.
Median enrollment 321 across the 156 interventional studies, 411 across the 95 observational. Of the 154 that completed or were terminated, 72 (47%) have results posted.
129 of 252 have an industry lead sponsor. The 10 most frequent:
Clinica Mediterranea is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Clinica Mediterranea has 2 studies filed under Atrial Fibrillation — fewer than ten, so there is no comparison to draw.
22 of the studies in Atrial Fibrillation with a site in Italy 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 |
| NCT07901699Società Italiana di Medicina InternaResumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation | 2026-11 |
| NCT05005949Medtronic Cardiac Ablation SolutionsSTOP Persistent AF PAS | 2026-12 |
| NCT07429214Biosense Webster, Inc.A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF | 2026-12-30 |
| NCT07428564Biosense Webster, Inc.A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF | 2026-12-30 |
Among the 252 studies in Atrial Fibrillation with a site in Italy, from their registry updates:
This is a prospective, multi-center, research study designed to evaluate the safety and efficacy of pulmonary vein (PV) isolation with high power short duration radiofrequency energy in patients with paroxysmal/persistent atrial fibrillation (AF).
Subjects with paroxysmal/persistent AF will undergo catheter ablation using commercially approved devices (mapping system and catheters).
Patients will be followed up for 12 months to measure the recurrence of AF and its predictors. The primary endpoint will be to investigate the association between clinical and procedural characteristics and the efficacy and the safety of PVI performed with HPSD.
At least 850 consecutive will be enrolled to have an adequate statistical power for the analysis of the primary endpoint. We assume that the freedom form AF recurrence at 12 months will be 80%. Expected R\^2 (Cox-Snell) 0.1. Candidate variables to be included in the model:10. Shrinkage level: 0.9. Based on these assumption the minimum number of patients is 850 with 170 events and EPP 17.
Patients will be screened in ambulatory and scheduled for AF ablation according to current guidelines. Ablation will be usually performed under effective oral anticoagulation. Anticoagulation could be withdrawn before admission, so as antiarrhythmic drugs will be removed before scheduled procedure. Patients in AF or with a CHA2DS2-VASc score ≥ 1 will undergo transesophageal echocardiography within 48 hours prior to the ablation. For all other patients transesophageal echocardiography is optional. Cardiac MRI or Cardiac CT scan could be executed as a reference for volume estimations obtained with the mapping system.
Ablation will be carried out under mild or deep sedation, or general anesthesia according to center preference. At least 2 femoral vein access will be obtained and in some patients 1 subclavian vein. One diagnostic catheter will be positioned in the coronary sinus. One or two transseptal accesses to the left atrium will be achieved using a standard approach. Then, the mapping catheter (LASSO, Penta-ray, Octa-ray catheter) and the ablation catheter (QDot Micro catheter) will be placed in the left atrium. Heparin will be administered before the transseptal punctures to maintain an activated clotting time ≥ 300 seconds for the duration of the procedure. Left atrium mapping will be performed in sinus rhythm. Patients with atrial fibrillation at the beginning of the index procedure will undergo electrical cardioversion. After left atrium reconstruction the effective PV-left atrium electrical connection will be checked with the mapping catheter. In all patients a wide antrum circumferential ablation aimed at PV isolation will be performed using the QDot Micro catheter in QMode+ mode (90 w for 4 sec) for the whole ablation or in an hybrid mode (QMode + for posterior wall and QMode guided by AI in the anterior wall), according to the operator preference. The maximum interlesion distance will be \<6 mm (16,17). According to operator preference it will be performed an ablation line encircling each PV or two ablation lines encircling the right and the left PVs. At the end of the ablation effective PV isolation (entry and exit block), will be checked with mapping catheter. After PV isolation will be achieved, the reconnection of the same vein will be evaluated after a 20 minute period from the initial isolation or after adenosine infusion or isoproterenol. If the vein reconnects to the atrium, the ablation will be directed to the gaps identified by the mapping catheter.
All patients will undergo a post-procedural ECG and, optional, an echocardiogram to exclude pericardial effusion or other acute complications.
After ablation, patients will undertake regular follow-up assessments (scheduled at 3 months) including a detailed history, physical examination, 12-lead standard electrocardiography, and 24-h Holter monitoring. Patients who will not report any symptoms related to the previous arrhythmia during a supplementary detailed follow up (6-12 months subsequent to catheter ablation) will be considered free of arrhythmia recurrence
Patients with paroxysmal/persistent AF with indication to catheter ablation according to current guidelines
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:
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.
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.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
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.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
Association between clinical and procedural characteristics and the percentage of arrhythmia recurrence rate after PV isolation performed with HPSD.
to assess the efficacy of the procedure in terms of atrial arrhythmia recurrence-free rate (binary outcome), with a number of candidate predictors equal to 10
Time frame: 12 months after ablation
Percentage of acute pulmonary vein reconnection reconnection
After PV isolation will be achieved, the reconnection of the same vein will be evaluated after a 20 minute period from the initial isolation or after adenosine infusion or isoproterenol.
Time frame: 20 minutes after ablation
Procedural time
The Investigators will calculate the overall procedural time (min)
Time frame: during the procedure
Percentage of patients with atrial arrhythmias recurrence during the blanking period
Number of patients with an atrial arrhythmia (atrial fibrillation, atrial tachycardia, atrial flutter) episode lasting at least 30 sec during the 3 month blanking period after the index ablation
Time frame: 3 months after ablation
Impact of anaesthesia type
The Investigators will evaluate the type of anesthesia: (mild sedation, deep sedation, general anesthesia), the anesthetic drugs used and their dose in mg
Time frame: during the procedure
Evaluation of pain perception during ablation
The Investigators will assess the pain during the ablation with a 0-10 pain scale (0 no pain, 1-3 mild, 4-6 moderate, 7-9 severe, 10 very severe).
Time frame: during the procedure
Fluoroscopy time
The Investigators will calculate the overall fluoroscopy time (sec)
Time frame: during the procedure
Radiofrequency time
The Investigators will calculate the overall radiofrequency time (sec)
Time frame: during the procedure
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events, acute and at 30-day and 12-month as assessed by CTCAE v4.0
Time frame: 30 days and 12 months after ablation
Plan to share: Yes — all collected IPD
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: starting 6 months after publication on primary end point
Access criteria: The data will be shared on reasonable request to the corresponding author
Started Jan 2023 (actual). Primary completion is estimated for Dec 2026, 47 months after the start.
Of 550 non-industry observational studies under Atrial Fibrillation, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 91. This study's planned 47 months is close to that.
Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Clinica Mediterranea