Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Biosense Webster, Inc.
- Enrollment
- 397
- Locations
- 41
- Primary Endpoint
- Number of Participants With Any Primary Adverse Events (PAE) That Occurred Within 7 Days Following Atrial Fibrillation (AF) Ablation Procedure Using HELIOSTAR Catheter
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.
Detailed Description
The STELLAR study is a pivotal, prospective, multicenter, single-arm, clinical evaluation of the Multi-Electrode RF Balloon catheter. The study will evaluate the safety and effectiveness of the Multi-Electrode RF Balloon catheter used for ablation in patients with paroxysmal atrial fibrillation (PAF).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation.
- •At least two symptomatic AF episodes within last six months from enrollment.
- •At least one ectrocardiographically documented AF episode within twelve (12) months prior to enrollment.
- •Failed at least one Class I or Class III antiarrhythmic drug.
- •Age 18 -75 years.
Exclusion Criteria
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- •Previous surgical or catheter ablation for AF.
- •Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF \> 7 days.
- •Any percutaneous coronary intervention within the past 2 months.
- •Valve repair or replacement or presence of a prosthetic valve.
- •Any carotid stenting or endarterectomy within the past 6 months.
- •Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months.
- •Documented left atrium (LA) thrombus within 1 day prior to the index procedure.
- •LA antero posterior diameter \> 50 mm.
- •Left Ventricular Ejection Fraction (LVEF) \< 40%.
Outcomes
Primary Outcomes
Number of Participants With Any Primary Adverse Events (PAE) That Occurred Within 7 Days Following Atrial Fibrillation (AF) Ablation Procedure Using HELIOSTAR Catheter
Time Frame: Within 7 days post-procedure (Day of procedure = Day 0)
An AE is any untoward medical occurrence in a participant whether or not related to the investigational medical device. PAEs included myocardial infarction, thromboembolism, transient ischemic attack, phrenic nerve paralysis, major vascular access complication/bleeding, pericarditis, pulmonary edema (respiratory insufficiency), stroke/cerebrovascular accident (CVA), hospitalization (initial or prolonged), device or procedure related death, atrio-esophageal fistula, pulmonary vein stenosis.
Number of Participants With Effectiveness Success
Time Frame: From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0)
Effectiveness success was defined as freedom from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; of unknown origin) episodes based on electrocardiographic data (greater than equal to \[\>=\] 30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365 post index procedure) and freedom from the following failure modes : freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from direct Current (DC) cardioversion failure, freedom from recurrence (captured on 12-lead electrocardiogram \[ECG\]) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin was defined as all AFL except those Cavo-Tricuspid Isthmus (CTI) dependent AFL as confirmed by accepted electrophysiology (EP) maneuvers (example, entrainment or activation mapping) in an EP study.
Secondary Outcomes
- Percentage of Participants With Acute Procedural Success(Day 0 (day of procedure))
- Percentage of Participants With Alternative 12-Month Success(From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0))
- Percentage of Participants With 12-Month Symptomatic Recurrence(From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0))
- Change From Baseline in Quality of Life as Assessed by Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Scale Score(Baseline, Month 12)
- Percentage of Participants With 12-Month Single Procedure Success(From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0))