Pulsed field ablation for atrial fibrillation in underrepresented minority patients

Prospective Multicenter Registry on the Clinical Outcomes and Safety of PFA for Atrial Fibrillation in Underrepresented Minorities (REPRESENT-PF Registry)

This registry will test how well Boston Scientific pulsed field ablation works and how safe it is for Black, Hispanic, Asian, and other underrepresented adults with paroxysmal or persistent atrial fibrillation.

Quick facts

• Study type: Observational
• Enrollment: 275 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (Academic / other)
• Locations: 2 sites (New York, New York and 1 other locations)
• Trial ID: NCT07535268 on ClinicalTrials.gov

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).

Who should consider this trial

Good fit: Adults (≥18) who identify as racial or ethnic minorities with symptomatic paroxysmal or persistent AF who are candidates for de novo ablation using Boston Scientific PFA catheters and can provide consent and attend follow-up are ideal candidates.

Not a fit: Patients with long-standing persistent AF (>1 year), those enrolled in other investigational trials, or those undergoing repeat ablation not originally in the registry are excluded and unlikely to benefit from this registry's findings.

Why it matters

Potential benefit: If successful, the registry could clarify PFA safety and effectiveness in minority populations and help expand equitable access to catheter ablation for AF.

How similar studies have performed: Pulsed field ablation has shown promising safety and at least comparable efficacy to thermal techniques in prior early studies, but registries specifically focused on underrepresented minorities are limited.

Eligibility criteria

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 this trial is running

New York, New York and 1 other locations

• 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

Conditions Persistent Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Pulsed Field Ablation