๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-09-04

Treatment of PAF With the Synaptic System (NCT05905835)

Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation With the Synaptic Compliant Cryoablation Balloon and System

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Synaptic Medical Corporation

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

Enrolled subjects will be treated with the Synaptic Cryoablation System. Treatment will include cryoablation of the pulmonary veins to achieve PVI. All subjects will be followed for twelve (12) months after completion of the index ablation procedure.

Who can join: Review the eligibility criteria below.

Location: Banner University Medical Center โ€” Phoenix, Arizona

Age range: 18 Years to 80 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 (10 Sites)

  • Banner University Medical Center โ€” Phoenix, Arizona
  • Dignity Health Arizona Research Enterprise โ€” Phoenix, Arizona
  • St. Bernard's Heart & Vascular โ€” Jonesboro, Arkansas
  • Cedars-Sinai Medical Center โ€” Los Angeles, California
  • Mercy General Hospital โ€” Sacramento, California
  • St. Luke's Mid America โ€” Kansas City, Missouri
  • Northwell Health - Lenox Hill Hospital โ€” New York, New York
  • Vanderbilt University Medical Center โ€” Nashville, Tennessee
  • Christus Health Frances Hospital โ€” Tyler, Texas
  • VCU Pauley Heart Center โ€” Richmond, 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†—