CompletedNot Applicable

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

United States458 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 range18 Years

SexALL

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

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 range18 Years

SexALL

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