πŸ›οΈ Verified NIH Record β€’ Updated 2026-07-23

Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF (NCT06099730)

🟒 Recruiting Observational / Diagnostic βš™οΈ Medical Device Protocol Sponsor: Massachusetts General Hospital

🩺 Plain-English Summary (8th-Grade Level)

The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the VARIPULSEβ„’ catheter and the TRUPULSEβ„’ generator.

Who can join: Review the eligibility criteria below.

Location: St. Bernard's Heart and Vascular Center β€” Jonesboro, Arkansas

Age range: 18 Years to 80 Years

πŸ§ͺ Interventions in This Study

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

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

πŸ“ All Participating Trial Locations (6 Sites)

  • St. Bernard's Heart and Vascular Center β€” Jonesboro, Arkansas
  • Massachusetts General Hospital β€” Boston, Massachusetts
  • Beth Israel Deaconess Medical Center β€” Boston, Massachusetts
  • Mount Sinai Hospital β€” New York, New York
  • Montefiore Medical Center β€” New York, New York
  • Texas Cardiac Arrhythmia Institute/Research Foundation β€” Austin, Texas

πŸ“ž Contact the Study Coordinator

Phone: (870) 935-6729

Email: krubino@dnairresearch.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° 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 Β§ 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.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  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.
πŸ›οΈ View Official NIH Record β†—