๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-04-09

Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias (NCT06765356)

๐Ÿ”ต Active, Not Recruiting Phase4 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Vivek Reddy

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the FARAPULSE catheter system (FARAWAVE catheter used in combination with the FARASTAR generator), to treat patients with atrial fibrillation during clinically-indicated ablation procedures

Who can join: Review the eligibility criteria below.

Location: Arrhythmia Research Group โ€” Jonesboro, Arkansas

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (9 Sites)

  • Arrhythmia Research Group โ€” Jonesboro, Arkansas
  • Cardiology Associates Medical Group โ€” Ventura, California
  • Naples Comprehensive Health โ€” Naples, Florida
  • Mount Sinai Morningside โ€” New York, New York
  • The Mount Sinai Hospital โ€” New York, New York
  • Ohio Health Research Institute โ€” Columbus, Ohio
  • UPMC Pinnacle Hospitals โ€” Harrisburg, Pennsylvania
  • Trident Medical Center โ€” North Charleston, South Carolina
  • Sentara Health Research Center โ€” Virginia Beach, Virginia

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—