An interventional study of SpherePVI™ Catheter in Atrial Fibrillation, sponsored by Medtronic Cardiac Ablation Solutions. Recruiting at 1 site in Lithuania. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Medtronic Cardiac Ablation Solutions (part of Medtronic) · Not applicable, Interventional, and Treatment
A prospective, single-arm, single-center study to evaluate the safety, performance, and effectiveness of the SpherePVI™ Catheter for treating paroxysmal AF.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 100 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Medtronic Cardiac Ablation Solutions is the lead sponsor of 37 studies on the registry; 9 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Symptomatic paroxysmal or persistent atrial fibrillation documented by:
Exclusion Criteria:
Subjects will not be eligible for the study if any of the following criteria are met:
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.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects treated with the SpherePVI™ Catheter
Device: SpherePVI™ Catheter
SpherePVI™ Catheter with the Affera Mapping and Ablation System
Percentage of subjects experiencing a primary safety event
The primary safety outcome is the incidence of the following serious device-related Primary Adverse Events (AEs): * Death (within 7 days) * Myocardial infarction (within 7 days) * Persistent phrenic nerve palsy (within 7 days) * Transient ischemic attack (TIA) (within 7 days) * Stroke/cerebrovascular accident (CVA) (within 7 days) * Thromboembolism (within 7 days) * Major vascular access complications / bleeding (within 7 days) * Heart block (within 7 days) * Gastroparesis (within 7 days) * Severe pericarditis (within 7 days) * Pulmonary edema (within 7 days) * Hospitalization (initial and prolonged) due to cardiovascular or pulmonary AE (within 7 days) * Cardiac tamponade / perforation (within 30 days) * Pulmonary vein stenosis (within 180 days) * Atrio-esophageal fistula (within 180 days)
Time frame: Up to 6 months
Percentage of subjects with acute procedure success
The primary efficacy outcome is acute electrical isolation of all pulmonary veins using the study device. Acute electrical isolation of all pulmonary veins is defined as confirmation of entrance block in all targeted pulmonary veins.
Time frame: During Procedure
Percentage of subjects experiencing a device- or procedure-related SAE
The secondary safety outcome is the incidence of device- or procedure-related SAEs as assessed at each follow-up visit.
Time frame: 12 months
Product performance evaluated on a 5-point semi-quantitative scale ("strongly disagree" to "strongly agree")
Acute product performance will be evaluated during the procedure and includes the following: * SpherePVI™ Catheter handling sufficient to reach reasonable intended targets, as determined by the physician: * catheter delivery to the desired ablation sites * completion of ablation procedure * safe removal of catheter from the subject * Electroanatomical navigation and/or mapping sufficient to aid the procedure (if used) * Generation of acceptable acute ablation lesions * Acute block across linear ablation lines (e.g. CTI flutter line), if performed
Time frame: During Procedure
Percentage of subjects free from documented recurrence outside of the blanking period
Chronic efficacy will be evaluated as freedom from documented arrhythmia recurrence outside of a 90-day blanking period. Failure will be reported as both (i) recurrence of AF and (ii) recurrence of any atrial tachyarrhythmia (AF, atrial tachycardia, or atrial flutter).
Time frame: 12 months
Percentage of pulmonary veins remaining isolated at remapping
Chronic efficacy evaluated as the number of pulmonary veins that remain isolated during an optional remapping procedure and will include the following: * The number of pulmonary veins that remain isolated * The number of patients with all pulmonary veins isolated * The number of previously ablated lines that remain blocked (when applicable)
Time frame: 75 days
Plan to share: No
Started Jul 2021 (actual). Primary completion is estimated for Sep 2029, 97 months after the start.
Of 255 industry-sponsored interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's planned 97 months is above that.
Counting every sponsor, half of 1,051 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.
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.
Medtronic Cardiac Ablation Solutions →