Tailored Catheter Ablation for Atrial Fibrillation
(RESTART Trial)

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Volta Medical

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing a computer program combined with a medical procedure to help patients whose irregular heartbeat has returned. The program helps doctors find and fix the problem areas in the heart more effectively.

Eligibility Criteria

This trial is for adults over 21 with recurrent Atrial Fibrillation (AF) after previous catheter or surgical ablation. Participants must have had symptomatic AF in the last year and been on anticoagulants like warfarin or NOACs for at least 4 weeks. Exclusions include severe heart failure, recent clots, major lung disease, very dilated Left Atrium, pregnancy, and certain other health conditions.

Inclusion Criteria

I have been on blood thinners like warfarin or NOAC for more than 4 weeks.

I have had symptoms of AF that lasted even 3 months after my last AF treatment.

Patients must be able and willing to provide written informed consent to participate in the clinical trial

+2 more

Exclusion Criteria

I have a history of abnormal blood clotting or bleeding.

I currently have an acute Covid-19 infection with fever or inflammation.

I have severe lung disease or chronic respiratory symptoms.

+28 more

Participant Groups

The study tests a tailored repeat catheter ablation approach using Volta's VX1 algorithm in patients whose AF returned after initial treatment. It's an international multi-center trial that isn't randomized; all participants receive the intervention to see how well it works.

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

Patients undergoing catheter ablation that qualify after initial screening.

Catheter Ablation is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Pulmonary Vein Isolation (PVI) for: