CompletedNot Applicable

Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

United States, Belgium, Canada458 participantsStarted 2020-06-24

Plain-language summary

To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Left ventricular ejection fraction (LVEF) \< 40% based on the most recent transthoracic echocardiogram (TTE) (≤180 days prior to enrollment);
. Left atrial diameter \> 55 mm OR left atrial volume \> 50 ml/m2 ml indexed based on the most recent TTE (≤ 180 days prior to enrollment);
. An implanted pacemaker, ICD, CRT device or an arrhythmia loop recorder;
. Previous cardiac surgery: i.e. ventriculotomy or atriotomy (excluding atriotomy for CABG);
. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve, including mitral valve clips;
. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occlude;
. Presence of a left atrial appendage occlusion device;
. Presence of any pulmonary vein stents;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Freedom From Primary Safety Events at 12 Months Post-procedure (Acute and Chronic Events) Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models

Timeframe: 12 Months

Percentage of Participants With Freedom From Treatment Failure at 12 Months Post-procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models

Timeframe: 12 Months

Percentage of Participants With Freedom From Primary Safety Events at 3 Months Post Procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx FIT Cryoablation Balloon Catheter Models

Timeframe: 3 months

Percentage of Participants With Acute Procedural Success Defined as the Achievement of Electrical Isolation of All PVs by Using the Boston Scientific Cardiac Cryoablation System With POLARx Fit Cryoablation Balloon Catheter Models

Timeframe: 1 day

Trial details

NCT IDNCT04133168

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-10

Results submitted2023-10-05

View on ClinicalTrials.gov More Paroxysmal Atrial Fibrillation trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Left ventricular ejection fraction (LVEF) \< 40% based on the most recent transthoracic echocardiogram (TTE) (≤180 days prior to enrollment);
. Left atrial diameter \> 55 mm OR left atrial volume \> 50 ml/m2 ml indexed based on the most recent TTE (≤ 180 days prior to enrollment);
. An implanted pacemaker, ICD, CRT device or an arrhythmia loop recorder;
. Previous cardiac surgery: i.e. ventriculotomy or atriotomy (excluding atriotomy for CABG);
. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve, including mitral valve clips;
. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occlude;
. Presence of a left atrial appendage occlusion device;
. Presence of any pulmonary vein stents;

What they're measuring

Timeframe: 12 Months

Percentage of Participants With Freedom From Treatment Failure at 12 Months Post-procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models

Timeframe: 12 Months

Timeframe: 3 months

Timeframe: 1 day