FARAPULSE Ablation for Atrial Fibrillation
(ReMATCH Trial)
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.12345
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.14567
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo repeat ablation of persistent atrial fibrillation using the FARAPULSE PFA System
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
Repeat Ablation of Persistent Atrial Fibrillation, including Mitral Isthmus Catheter Ablation, with the FARAPULSE Pulsed Field Ablation System.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Scientific Corporation
Lead Sponsor
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
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 ...
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) ...
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 ...
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 ...
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 ...
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 ...
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 ...
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