CompletedPhase 3

Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

United States397 participantsStarted 2018-10-22

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

Number of Participants With Any Primary Adverse Events (PAE) That Occurred Within 7 Days Following Atrial Fibrillation (AF) Ablation Procedure Using HELIOSTAR Catheter

Timeframe: Within 7 days post-procedure (Day of procedure = Day 0)

Number of Participants With Effectiveness Success

Timeframe: From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0)

Trial details

NCT IDNCT03683030

SponsorBiosense Webster, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-18

Results submitted2025-07-30

View on ClinicalTrials.gov More Atrial Fibrillation trials