Recruiting

PFA

Sponsor:

Vivek Reddy

Code:

NCT07535268

Conditions

Persistent Atrial Fibrillation

Paroxysmal Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FARAWAVE Pulsed Field Ablation Catheter

Study Details

Brief summary:

This pragmatic, prospective, single-arm, multi-center, observational registry will evaluate the safety and effectiveness of PFA for the treatment of atrial fibrillation in underrepresented minority patients using FDA approved Boston Scientific PFA catheters; all data collected will be standard of care.

Conditions

Persistent Atrial Fibrillation

Paroxysmal Atrial Fibrillation

Study ID

NCT07535268

Start date

Mar 30, 2026

Status verified date

Apr, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

275 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients indicated for atrial arrhythmia ablation

All patients will receive standard of care treatment.

Interventions

FARAWAVE Pulsed Field Ablation Catheter

The FARAWAVE Pulsed Field Ablation (PFA) Catheter is a component of the FARAPULSE PFA System. The FARAWAVE Catheter is an over-the-wire, multi-electrode catheter designed to deliver PFA energy to the distal section for cardiac ablation. The FARAWAVE Catheter is indicated for: 1) the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF) 2) the isolation of pulmonary veins and the posterior wall in the treatment of drug-refractory, symptomatic Persistent Atrial Fibrillation (episode duration less than one year) This device is FDA approved.

Primary outcome measure

  • Composite Serious Adverse Events [ Time Frame: up to Day 60 Post Procedure ]
  • Chronic Treatment Success [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Devin Chamberlain

(646) 984-1049devin.chamberlain@mountsinai.org

Betsy Ellsworth, MSN, ANP

Betsy.ellsworth@mountsinai.org

Locations

The Mount Sinai Hospital

Recruiting

New York, New York, United States, 10030

Contacts

Devin Chamberlain

(646) 984-1049devin.chamberlain@mountsinai.org

Principal Investigator:

Joshua Lampert, MD

Valley Health System

Recruiting

Winchester, Virginia, United States, 22601

Contacts

Lauren Peterson

lpeterso@valleyhealthlink.com

More Information

Sponsor

Vivek Reddy

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • Paroxysmal Atrial Fibrillation
  • Persistent Atrial Fibrillation
  • Pulsed Field Ablation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vivek Reddy on 2026-04-17.