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NCT06324201 · ClinicalTrials.gov registry record
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.
A clinical trial of Paroxysmal Atrial Fibrillation, sponsored by Heart Rhythm Clinical and Research Solutions.
- Recruiting
- Registry status
- 250
- Enrollment target
- 20
- Study locations
NCT06324201: Recruiting study of Paroxysmal Atrial Fibrillation, sponsored by Heart Rhythm Clinical and Research Solutions.
NCT06324201 is a study of Paroxysmal Atrial Fibrillation that is actively recruiting participants, run by Heart Rhythm Clinical and Research Solutions. The registered enrollment target is 250 participants, below the 849-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06324201, a study of Paroxysmal Atrial Fibrillation, is actively recruiting participants, sponsored by Heart Rhythm Clinical and Research Solutions.
- RECRUITING
- Registry status
- 250 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Adverse events from post-procedure through 7-day post ablation visit.
Conditions Studied
Interventions
- DEVICE Ablation Procedure
Study Locations (20)
Virginia
- Centra Health, Inc.dba Stroobants Cardiovascular Center - Lynchburg
- Bon Secours Medical Group - Richmond Specialty Care - Richmond
- Valley Health System - Winchester
Alabama
- Arrhythmia Institute at Grandview - Birmingham
- Mobile Cardiology Associates - Mobile
Florida
- Naples Community Hospital - Naples
- Sarasota Memorial Health - Sarasota
Michigan
- Sparrow Clinical Research Institute - Lansing
- Trinity Health-Michigan Heart - Ypsilanti
Ohio
- The Christ Hospital - Cincinnati
- University of Cincinnati - Cincinnati
Pennsylvania
- University of Pennsylvania (UPENN) - Philadelphia
- Allegheny Health - Pittsburgh
Washington
- Multicare Health Systems-Pulse Heart - Puyallup
- Franciscan Heart and Vascular Associates - Tacoma
California
- Community Memorial Health System - Ventura
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2024-02-27 |
| Est. Completion | 2028-03 |
What NCT06324201 shows while recruiting
NCT06324201 is an observational study that tracks outcomes without assigning an intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 849-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Paroxysmal Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which Ablation Procedure is the first listed.
NCT06324201 names 20 study sites across 12 states, led by Virginia, Alabama, Florida.
Frequently Asked Questions
What is clinical trial NCT06324201 about?
NCT06324201 is a clinical study titled "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.". 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-s...
What is the current status of trial NCT06324201?
This trial is currently recruiting. The enrollment target is 250 participants. The study started on 2024-02-27. Estimated completion is 2028-03.
What conditions does trial NCT06324201 study?
This clinical trial studies the following conditions: Paroxysmal Atrial Fibrillation.
What interventions are being tested in trial NCT06324201?
The interventions under investigation include: Ablation Procedure (DEVICE).
Who is sponsoring clinical trial NCT06324201?
This trial is sponsored by Heart Rhythm Clinical and Research Solutions, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06324201 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06324201's enrollment target sits among peer trials
250 10th of 24 higher than 14 of 24 other Paroxysmal Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Paroxysmal Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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