Catheter Ablation for Atrial Fibrillation
(PulseSmart Trial)

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Biosense Webster, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow \[STSF\] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow.

Eligibility Criteria

This trial is for individuals with paroxysmal atrial fibrillation (PAF), which is an irregular heartbeat that disrupts normal blood flow. Participants must have symptoms that haven't improved with medication. Specific eligibility details are not provided, but typically participants should be adults in stable health condition.

Inclusion Criteria

Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements

I have been diagnosed with PAF and had at least one AF episode in the last year.

I've had a bad reaction or no improvement from a specific heart rhythm medication.

+1 more

Exclusion Criteria

I have had previous ablation or surgery for atrial fibrillation.

Current enrollment in an investigational study evaluating another device or drug

I had a minor stroke within the last year.

+29 more

Participant Groups

The study tests the safety and effectiveness of a new ablation system called THERMOCOOL SMARTTOUCH SF catheter paired with the TRUPULSE generator. This system aims to isolate atrial pulmonary veins to help control irregular heartbeats in PAF patients.

1Treatment groups

Experimental Treatment

Group I: Pulsed Field (PF)/Radiofrequency (RF) Ablation SystemExperimental Treatment1 Intervention

Participants with drug refractory symptomatic PAF who are candidates for atrial fibrillation ablation uses PF and RF energy to produce targeted intracardiac lesions for the treatment of atrial fibrillation.