๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-10-29

The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation. (NCT06324201)

The Long-term Safety and Effectiveness Evaluation of the QDOT MICROโ„ข System Use in Conjunction With VISITAG SURPOINTโ„ขModule for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Heart Rhythm Clinical and Research Solutions, LLC

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

Observational, multi-center, non-randomized, post-market study. This is a nested sub-study of the REAL AF Registry. Consecutive symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients from the registry will be screened for enrollment, prospectively or retrospectively, to this sub-study per inclusion and exclusion criteria.

Who can join: Review the eligibility criteria below.

Location: Arrhythmia Institute at Grandview โ€” Birmingham, Alabama

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 (21 Sites)

  • Arrhythmia Institute at Grandview โ€” Birmingham, Alabama
  • Mobile Cardiology Associates โ€” Mobile, Alabama
  • Community Memorial Health System โ€” Ventura, California
  • Medical City - HCA โ€” Aurora, Colorado
  • Naples Community Hospital โ€” Naples, Florida
  • Sarasota Memorial Health โ€” Sarasota, Florida
  • Piedmont Healthcare โ€” Atlanta, Georgia
  • Norton Heart and Vascular Institute โ€” Louisville, Kentucky
  • The Brigham and Womens Hospital โ€” Boston, Massachusetts
  • Sparrow Clinical Research Institute โ€” Lansing, Michigan
  • Trinity Health-Michigan Heart โ€” Ypsilanti, Michigan
  • The Christ Hospital โ€” Cincinnati, Ohio
  • University of Cincinnati โ€” Cincinnati, Ohio
  • University of Pennsylvania (UPENN) โ€” Philadelphia, Pennsylvania
  • Allegheny Health โ€” Pittsburgh, Pennsylvania
  • Centra Health, Inc.dba Stroobants Cardiovascular Center โ€” Lynchburg, Virginia
  • Bon Secours Medical Group - Richmond Specialty Care โ€” Richmond, Virginia
  • Valley Health System โ€” Winchester, Virginia
  • Multicare Health Systems-Pulse Heart โ€” Puyallup, Washington
  • Franciscan Heart and Vascular Associates โ€” Tacoma, Washington
  • Mercy Health โ€” Janesville, Wisconsin

๐Ÿ“ž Contact the Study Coordinator

Phone: (615) 448-5770

Email: jmoss@hrcrs.com

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

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. 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.
๐Ÿ›๏ธ View Official NIH Record โ†—