FARAPULSE Ablation for Atrial Fibrillation

(ReMATCH Trial)

Overseen By Kristin Mathson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Must not be taking: Phosphodiesterase inhibitors

Disqualifiers: Heart failure, Hypertension, Diabetes, Renal insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

407 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters.

Who Is on the Research Team?

Moussa Mansour,, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for people who've had one atrial fibrillation ablation within the last 5 years and have persistent AF, documented by a monitoring device, that doesn't stop after 7 days or needs cardioversion. Participants must be able to give informed consent and commit to all follow-up tests at an approved center.

Inclusion Criteria

I have had persistent atrial fibrillation recorded within the last 6 months.

I am willing and able to attend all follow-up visits for this study.

I had one AF ablation procedure within the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo repeat ablation of persistent atrial fibrillation using the FARAPULSE PFA System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• FARAPULSE Pulsed Field Ablation System

Trial Overview The ReMATCH Study is testing the FARAPULSE Pulsed Field Ablation System, including specific catheters designed for this procedure. It's a prospective study where all participants receive the same treatment without comparison groups.

How Is the Trial Designed?

Group I: Single Arm Prospective Experimental Treatment 1 Intervention

Repeat Ablation of Persistent Atrial Fibrillation, including Mitral Isthmus Catheter Ablation, with the FARAPULSE Pulsed Field Ablation System.

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology