FARAPULSE Ablation for Atrial Fibrillation

(ReMATCH Trial)

Recruiting at 15 trial locations

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?

This trial tests a new treatment for individuals with persistent atrial fibrillation (AF), a condition where the heart beats irregularly and may cause serious health issues. The treatment employs the FARAPULSE Pulsed Field Ablation System, a device designed to improve heart rhythm by targeting specific areas of the heart. Ideal participants have experienced irregular heartbeats following a previous AF procedure.

As an unphased trial, this study allows participants to contribute to innovative research that could enhance future AF treatments.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you cannot use phosphodiesterase inhibitors within 24 hours of the ablation procedure and must be willing to use anticoagulation medications as required.

What prior data suggests that the FARAPULSE Pulsed Field Ablation System is safe for atrial fibrillation treatment?

Research has shown that the FARAPULSE Pulsed Field Ablation System is generally safe for treating atrial fibrillation, an irregular heartbeat. In one study, the main safety issues affected 2.3% of patients, including cases of pericarditis (inflammation of the heart lining) and heart attacks. These events were rare, indicating that most patients tolerate the treatment well. Although some complications have been reported, they remain uncommon. Overall, the system appears to be a safe option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The FARAPULSE Pulsed Field Ablation System is unique because it uses a novel technology called pulsed field ablation (PFA) to treat atrial fibrillation. Unlike standard treatments, which often rely on thermal energy to destroy problematic heart tissue, PFA uses electrical fields to selectively target heart cells while sparing surrounding tissues. This precision reduces the risk of damage to nearby structures and may lead to fewer complications. Researchers are excited about this approach because it promises a safer, more efficient method for managing persistent atrial fibrillation, potentially improving patient outcomes.

What evidence suggests that the FARAPULSE Pulsed Field Ablation System is effective for atrial fibrillation?

Research has shown that the FARAPULSE Pulsed Field Ablation System effectively treats atrial fibrillation, an irregular and often rapid heartbeat. One study reported that 63.5% of patients with ongoing atrial fibrillation experienced successful results after one year. Another study found a 67.7% success rate for patients with constant atrial fibrillation. Additionally, 97.2% of patients were free from atrial flutter, another type of irregular heartbeat. These findings suggest that FARAPULSE could be a promising option for those with persistent atrial fibrillation. Participants in this trial will receive treatment with the FARAPULSE Pulsed Field Ablation System in a single-arm prospective study. ^{1 4 5 6 7}

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

Citations

1. jacc.org jacc.org/doi/10.1016/j.jacc.2025.03.515

Pulsed Field Ablation for Persistent Atrial Fibrillation Primary effectiveness was 63.5% (57.3% lower confidence limit) at 1 year, with 8.5% patients having a single, isolated atrial fibrillation ...

2. academic.oup.com academic.oup.com/europace/article/27/9/euaf182/8244658

one-year outcomes of the FARADISE registry | EP Europace The study demonstrates high clinical effectiveness at 12-months: 80.8% in paroxysmal and 67.7% in non-paroxysmal atrial fibrillation (AF) ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0735109725059911

Pulsed Field Ablation for Persistent Atrial Fibrillation Primary effectiveness was 63.5% (57.3% lower confidence limit) at 1 year, with 8.5% patients having a single, isolated atrial fibrillation ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.125.074485

Pulsed Field Ablation of Persistent Atrial Fibrillation With ... Freedom from recurrent atrial flutter was 97.2%. Detailed analysis of the full insertable cardiac monitor data revealed freedom from AA of ≥30 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11782097/

Effectiveness and Safety of Pulsed Field Ablation in Patients ... PFA was associated with a lower incidence of atrial arrhythmia recurrence after 3 months and phrenic nerve paralysis or injury, but a higher ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.064959

Safety and Effectiveness of Pulsed Field Ablation to Treat ... But most importantly, the primary effectiveness outcome of freedom from AF/AFL/AT recurrence >30 seconds postblanking was 78.1% after a single ablation ...

7. farapulse.com farapulse.com/us/en/home.html

FARAPULSE™ Pulsed Field Ablation (PFA) System Safety and effectiveness of pulsed field ablation to treat atrial fibrillation: one-year outcomes from the MANIFEST-PF registry. Circulation. 2023 May 18 ...