Phase 3
N=397
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03683030 ↗Enrolled (actual)
397
Serious AEs
19.5%
Results posted
Aug 2025
Primary outcome: Primary: Number of Participants With Any Primary Adverse Events (PAE) That Occurred Within 7 Days Following Atrial Fibrillation (AF) Ablation Procedure Using HELIOSTAR Catheter — 4; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Multi-Electrode RF Balloon Catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biosense Webster, Inc.
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Primary Adverse Events (PAE) That Occurred Within 7 Days Following Atrial Fibrillation (AF) Ablation Procedure Using HELIOSTAR Catheter |
4; 13 | — |
| PRIMARY Number of Participants With Effectiveness Success |
62; 170 | — |
| SECONDARY Percentage of Participants With Acute Procedural Success |
100; 98.8 | — |
| SECONDARY Percentage of Participants With Alternative 12-Month Success |
67.7; 69.6 | — |
| SECONDARY Percentage of Participants With 12-Month Symptomatic Recurrence |
75.3; 74.3 | — |
| SECONDARY Change From Baseline in Quality of Life as Assessed by Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Scale Score |
33.37; 35.90 | — |
| SECONDARY Percentage of Participants With 12-Month Single Procedure Success |
67.7; 68.4 | — |
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.
Eligibility Criteria
Key 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.
Key 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%.
- Contraindication to anticoagulation (e.g., heparin).
- Myocardial infarction within the past 2 months.
- Documented thromboembolic event (including transient ischemic attack) within the past 12 months.
- Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
- Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
- Women who are pregnant, lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
- Life expectancy or other disease processes likely to limit survival to less than 12 months.
Data sourced from ClinicalTrials.gov (NCT03683030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.