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
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• ≥ 18 years of age, or older if required by local law
• Single previous AF ablation procedure for Paroxysmal Atrial Fibrillation (PAF) or Persistent AF (PersAF)that minimally included pulmonary vein isolation that occurred within 5 years prior to enrollment.
• Documented (physician's note) diagnosis of PersAF either prior to the subject's Index Procedure OR development of PersAF after the Index Procedure.
• Documented evidence of AF recurrence at least 60 days after the subject's Index Procedure, captured by any regulatory cleared rhythm monitoring device.
⁃ OR
• If diagnosed with PersAF prior to the Index Procedure, documented recurrence of AF or atypical AFL at least 60 days after the Index Procedure, captured by any regulatory cleared rhythm monitoring device.
• Willing and capable of providing informed consent
• Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center
Locations
United States
Alabama
Mobile Infirmary Medical Center
RECRUITING
Mobile
Arkansas
Arrhythmia Research Group-Research Facility
RECRUITING
Jonesboro
California
University of Southern California Hospital
RECRUITING
Los Angeles
Florida
HCA Florida Mercy Hospital
RECRUITING
Miami
Georgia
Emory University Hospital
RECRUITING
Atlanta
Memorial Health University Medical Center
RECRUITING
Savannah
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Southcoast Physicians Group
RECRUITING
Fall River
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
New Jersey
Virtua Health Inc.
RECRUITING
Marlton
Ohio
Bethesda North Hospital
RECRUITING
Cincinnati
Ohio State University Medical Center
RECRUITING
Columbus
South Carolina
Trident Medical Center
RECRUITING
Charleston
Texas
Texas Cardiac Arrhythmia Research
RECRUITING
Austin
Christus Trinity Mother Frances Health System
RECRUITING
Tyler
Virginia
Sentara Norfolk General Hospital
RECRUITING
Norfolk
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Kristin Mathson
Kristin.Mathson@bsci.com
612.417.9538
Backup
Kaitlyn Aldrich
kaitlyn.aldrich@bsci.com
+16515824790
Time Frame
Start Date:2025-06-03
Estimated Completion Date:2028-01
Participants
Target number of participants:407
Treatments
Other: Single Arm Prospective
Repeat Ablation of Persistent Atrial Fibrillation, including Mitral Isthmus Catheter Ablation, with the FARAPULSE Pulsed Field Ablation System.