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NCT00523978 · ClinicalTrials.gov registry record · Phase 3
A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation
A Phase 3 study of Paroxysmal Atrial Fibrillation, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- Phase 3
- Development phase
- 245
- Enrollment target
- 20
- Study locations
NCT00523978: Completed Phase 3 study of Paroxysmal Atrial Fibrillation, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT00523978 is a Phase 3 study of Paroxysmal Atrial Fibrillation that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 245 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 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00523978, a Phase 3 study of Paroxysmal Atrial Fibrillation, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 245 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Acute Procedural Success was defined as a demonstration of electrical isolation in ≥ 3 Pulmonary Veins (PVs) at the conclusion of the first protocol-defined cryoablation procedure. APS was decided at the end of the procedure the mean time was calculated for the time frame.
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 |
What the finished NCT00523978 record still lists
NCT00523978 is an interventional study that assigns participants to a tested intervention. The registered 245 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 2 interventions - of which Arctic Front® Cryoablation Catheter is the first listed.
NCT00523978 names 20 study sites across 15 states, led by California, Florida, Georgia.
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.
What interventions are being tested in trial NCT00523978?
The interventions under investigation include: Arctic Front® Cryoablation Catheter (DEVICE), Flecainide or Sotalol or Propafenone (DRUG).
Who is sponsoring clinical trial NCT00523978?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT00523978's enrollment target sits among peer trials
245 12th of 24 higher than 13 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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