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A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation
NCT00523978 · View on ClinicalTrials.gov ↗
Study Summary
This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada. Subjects with paroxysmal atrial fibrillation (PAF) referred for ablative intervention after efficacy failure of one or more Study Atrial Fibrillation (AF) Drugs (flecainide, propafenone or sotalol) were randomized 2:1 to cryoablation intervention (Experimental Subjects, ES) or to a Study AF Drug (Control Subjects, CS). Subjects were followed for 12 months with scheduled and symptom-driven assessments to detect recurrent atrial fibrillation by means of periodic electrocardiograms, weekly scheduled trans-telephonic monitoring, patient-initiated trans-telephonic monitoring, and 24-hour Holter monitoring at 6 and 12 months. The first 90 days after study therapy was initiated was considered a blanked period for all subjects.
Conditions Studied
Interventions
- DEVICE Arctic Front® Cryoablation Catheter
- DRUG Flecainide or Sotalol or Propafenone
Study Locations (20)
California
- Cedar Sinai Medical Center — Los Angeles
- UC Davis Medical Center — Sacramento
- Stanford Hospital — Stanford
Florida
- Mayo Clinic- Jacksonville — Jacksonville
- BayHeart Group -- St-Joseph's Hospital — Tampa
Georgia
- Emery Crawford Long Hospital — Atlanta
- Piedmont Hospital — Atlanta
Virginia
- Inova Research Center — Falls Church
- Sentara CV Research Institute — Norfolk
Alabama
- University of Alabama — Birmingham
Arizona
- Banner Good Samaritan Medical Center — Phoenix
Colorado
- Colorado Cardiac Alliance -- Memorial Hospital — Colorado Springs
Iowa
- Iowa Heart Center — Des Moines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2006-10 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00523978
The ClinicalTrials.gov registry entry for NCT00523978 describes a study currently listed as completed. It is categorized as Phase 3, 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 245 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiac Rhythm and Heart Failure, which has 56 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 2 interventions — of which Arctic Front® Cryoablation Catheter 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: NCT00523978 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, Georgia. 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 NCT00523978 about?
NCT00523978 is a clinical study titled "A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation". This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada. Subjects with paroxysmal atrial fibrillation (PAF) referred for ablative intervention after efficacy failure of one or mor...
What is the current status of trial NCT00523978?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 245 participants. The study started on 2006-10. Estimated completion is 2011-07.
What conditions does trial NCT00523978 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 NCT00523978?
The interventions under investigation include: Arctic Front® Cryoablation Catheter (DEVICE), Flecainide or Sotalol or Propafenone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00523978?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00523978 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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