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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 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06324201
The ClinicalTrials.gov registry entry for NCT06324201 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Heart Rhythm Clinical and Research Solutions, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06324201 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Virginia, Alabama, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06324201?
The interventions under investigation include: Ablation Procedure (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06324201?
This trial is sponsored by Heart Rhythm Clinical and Research Solutions, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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