NCT06324201Recruiting
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.
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
Source: ClinicalTrials.gov · Last updated 31 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 21 Feb 2024
- Start date
- 27 Feb 2024
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
- Diseases
- Atrial fibrillation
- NCT number
- NCT06324201
What you commit to
- Study type: Observational
- Planned participants: 250
- From 27 Feb 2024 to the primary completion date, 31 Mar 2026
- 21 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
Other
- Patients who have undergone catheter ablation for atrial fibrillation (PVI, roof line, posterior wall ablation...)
- Persistent or long-standing persistent AF
- In the opinion of the investigator, any known contraindication to an ablation procedure
Who the study is looking for
- Symptomatic drug refractory paroxysmal (AF episode terminate spontaneously within 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
- 18 years of age or older
- Able and willing to participate in baseline and follow up evaluations for the full length of the sub-study
- Willing and able to provide informed consent for this sub-study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Piedmont Healthcare Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Medical City - HCA Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Arrhythmia Institute at Grandview Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| The Brigham and Womens Hospital Coordinator of this site? Confirm its status | Boston | United States | Not yet recruiting |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| The Christ Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Mercy Health Coordinator of this site? Confirm its status | Janesville | United States | Recruiting |
| Sparrow Clinical Research Institute Coordinator of this site? Confirm its status | Lansing | United States | Recruiting |
| Norton Heart and Vascular Institute Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Centra Health, Inc. dba Stroobants Cardiovascular Center Coordinator of this site? Confirm its status | Lynchburg | United States | Recruiting |
| Mobile Cardiology Associates Coordinator of this site? Confirm its status | Mobile | United States | Recruiting |
| Naples Community Hospital Coordinator of this site? Confirm its status | Naples | United States | Withdrawn |
| University of Pennsylvania (UPENN) Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Allegheny Health Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Multicare Health Systems-Pulse Heart Coordinator of this site? Confirm its status | Puyallup | United States | Recruiting |
| Bon Secours Medical Group - Richmond Specialty Care Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Sarasota Memorial Health Coordinator of this site? Confirm its status | Sarasota | United States | Recruiting |
| Franciscan Heart and Vascular Associates Coordinator of this site? Confirm its status | Tacoma | United States | Recruiting |
| Community Memorial Health System Coordinator of this site? Confirm its status | Ventura | United States | Recruiting |
| Valley Health System Coordinator of this site? Confirm its status | Winchester | United States | Recruiting |
| Trinity Health Michigan Heart Coordinator of this site? Confirm its status | Ypsilanti | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.