Ablation Procedures for Atrial Fibrillation
(PVS-PVI Trial)

Recruiting in Palo Alto (17 mi)

Overseen byRamesh Hariharan, D, MRCP,FACC, FHRS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The University of Texas Health Science Center, Houston

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare procedural times and Radiofrequency (RF)applications required for Pulmonary vein myocardial sleeves targeted pulmonary vein ablation (PVS-PVI) , to compare the efficacy of PVS-PVI , to compare the safety of PVS-PVI and to assess other clinical outcomes of PVS-PVI in individuals with symptomatic paroxysmal Atrial fibrillation (AF) using Omnipolar Technology with conventional Wide area circumferential ablation (WACA).

Eligibility Criteria

This trial is for individuals with symptomatic paroxysmal Atrial Fibrillation (AF), a type of irregular heartbeat. Participants should be suitable candidates for the ablation procedures being tested. Specific inclusion and exclusion criteria details are not provided, but typically these would relate to overall health status and any contraindications for the procedures.

Inclusion Criteria

I have AFib that hasn't improved with at least one medication, or I can't tolerate the medication.

I am capable of understanding and agreeing to the trial's terms.

A minimum of one documented AF episode via 12-lead ECG, Holter monitor, or loop recorder

Exclusion Criteria

I have had a procedure to correct heart rhythm problems.

I have a serious heart valve problem.

My atrial fibrillation can be treated or reversed.

See 6 more

Treatment Details

Interventions

PVS-PVI targeted ablation (Procedure)
Wide area circumferential ablation (WACA) (Procedure)

Trial OverviewThe study compares two types of heart ablation techniques: PVS-PVI that targets pulmonary vein myocardial sleeves using Omnipolar Technology, and conventional WACA. It aims to evaluate which method is more effective in terms of procedure time, safety, number of RF applications needed, and other clinical outcomes.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: PVS-PVIExperimental Treatment1 Intervention

Group II: WACAActive Control1 Intervention