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NCT01456949 · ClinicalTrials.gov registry record · NA
Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
A NA study of Paroxysmal Atrial Fibrillation (PAF), sponsored by Medtronic Cardiac Ablation Solutions.
- Completed
- Registry status
- NA
- Development phase
- 402
- Enrollment target
- 20
- Study locations
NCT01456949: Completed NA study of Paroxysmal Atrial Fibrillation (PAF), sponsored by Medtronic Cardiac Ablation Solutions.
NCT01456949 is a NA study of Paroxysmal Atrial Fibrillation (PAF) that has completed, run by Medtronic Cardiac Ablation Solutions. The registered enrollment target is 402 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01456949, a NA study of Paroxysmal Atrial Fibrillation (PAF), has completed, sponsored by Medtronic Cardiac Ablation Solutions.
- COMPLETED
- Registry status
- NA
- Development phase
- 402 participants
- Enrollment target
- 20
- Study locations
Study Summary
The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front® Cardiac CryoAblation System.
Primary Outcome
Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs). Chronic treatment failure is defined as: * Documented atrial fibrillation lasting longer than 30 seconds (outside the 90 day blanking period) OR * Intervention for atrial fibrillation (except for repeat cryoablation during the 90 day blanking period)
Conditions Studied
Interventions
- DEVICE Medtronic Arctic Front® Cardiac CryoAblation System
Study Locations (20)
Florida
- Daytona Heart Group - Daytona Beach
- Broward General Medical Center - Fort Lauderdale
- University of Florida - Gainesville
Minnesota
- Metropolitan Cardiology Consultants PA - Coon Rapids
- St. Mary's Hospital - Mayo Clinic - Rochester
- HealthEast St. Joseph's Hospital - Saint Paul
Georgia
- Emory University Hospital - Atlanta
- WellStar Kennestone Hospital - Marietta
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
Alaska
- Alaska Heart Institute - Anchorage
Arizona
- Banner Good Samaritan Medical Center - Phoenix
California
- Good Samaritan Hospital - San Jose
Colorado
- Colorado Heart and Vascular - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 402 participants |
| Start Date | 2012-06-26 |
| Est. Completion | 2017-11-30 |
| Phase | NA |
What the finished NCT01456949 record still lists
NCT01456949 is an interventional study that assigns participants to a tested intervention. The registered 402 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Paroxysmal Atrial Fibrillation (PAF) appearing as the primary indexed condition, and to 1 intervention - of which Medtronic Arctic Front® Cardiac CryoAblation System is the first listed.
NCT01456949 names 20 study sites across 14 states, led by Florida, Minnesota, Georgia.
Frequently Asked Questions
What is clinical trial NCT01456949 about?
NCT01456949 is a clinical study titled "Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)". The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front® Cardiac CryoAblation System.
What is the current status of trial NCT01456949?
This trial is currently completed. It is a NA study. The enrollment target is 402 participants. The study started on 2012-06-26. Estimated completion is 2017-11-30.
What conditions does trial NCT01456949 study?
This clinical trial studies the following conditions: Paroxysmal Atrial Fibrillation (PAF).
What interventions are being tested in trial NCT01456949?
The interventions under investigation include: Medtronic Arctic Front® Cardiac CryoAblation System (DEVICE).
Who is sponsoring clinical trial NCT01456949?
This trial is sponsored by Medtronic Cardiac Ablation Solutions, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01456949 being conducted?
This trial has 20 study locations across Alaska, 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 NCT01456949's enrollment target sits among peer trials
402 245th of 2000 higher than 1,755 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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