Pulsed field ablation for atrial fibrillation in underrepresented minority patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

REPRESENT-PF is a pragmatic, prospective, single-arm, multi-center observational registry that enrolls consecutive racial and ethnic minority patients undergoing de novo pulsed field ablation (PFA) for symptomatic paroxysmal or persistent atrial fibrillation using FDA‑approved Boston Scientific PFA catheters. All data collected are from standard-of-care procedures and scheduled baseline and follow-up visits. The registry will capture safety events, procedural details, and effectiveness outcomes to describe real-world performance of PFA in populations historically underrepresented in AF ablation research. Sites include participating U.S. centers such as The Mount Sinai Hospital (New York) and Valley Health System (Winchester, Virginia).

Why it matters

Who can join: the full rules

Inclusion Criteria:

* All consecutive patients classified as racial or ethnic minorities undergoing ablation using Boston Scientific FDA approved PFA catheters for AF will be included.
* De novo ablation for symptomatic paroxysmal and persistent AF (Age ≥ 18) (unless it is a repeat for a patient whose index procedure is also in the registry) who are deemed to be candidates for AF ablation by the investigator.
* Able and willing to participate in baseline and follow up evaluation over the study period
* Willing and able to provide informed consent, if applicable.

Exclusion Criteria:

* Enrolled in an investigational drug or device clinical trial or any other trial with outlined treatment plan
* Long standing persistent AF (AF \> 1 year duration)
* Repeat ablation, unless index ablation procedure was in the REPRESENT-PF registry
* Any known contra-indication to ablation procedure at the discretion of the investigator

Where it's running

• The Mount Sinai Hospital
  New York, New York, United States Recruiting
• Valley Health System
  Winchester, Virginia, United States Recruiting

Study contacts

• Principal investigator: Vivek Reddy, MD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Devin Chamberlain
• Email: devin.chamberlain@mountsinai.org
• Phone: (646) 984-1049

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Real-world experience of catheter ablation for atrial fibrillation

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  Recruiting at 70 sites Heart Rhythm Clinical and Research Solutions, LLC · Birmingham, Alabama and 74 other locations · NCT04088071

• Conscious Sedation vs General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation

  This trial tests whether local anesthesia with conscious sedation can match general anesthesia for pulsed field ablation in adults with paroxysmal atrial fibrillation.

  Recruiting China National Center for Cardiovascular Diseases · Beijing, Beijing Municipality · NCT07877519

• FARAFLEX Mapping and Pulsed Field Ablation for Atrial Fibrillation

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• Left Atrial Appendage Occlusion and Rhythm Restoration in AF Patients

  This trial tests a combined procedure using the Volt PFA System and Amulet 2 to see if it safely and feasibly treats atrial fibrillation while also closing the left atrial appendage in adults with AF.

  Recruiting at 13 sites Abbott Medical Devices · Brussels, B CAP R and 15 other locations · NCT07523620

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.