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NCT03012841 · ClinicalTrials.gov registry record · NA
STOP Persistent AF
A NA study of Atrial Fibrillation, sponsored by Medtronic Cardiac Ablation Solutions.
- Completed
- Registry status
- NA
- Development phase
- 186
- Enrollment target
- 20
- Study locations
NCT03012841: Completed NA study of Atrial Fibrillation, sponsored by Medtronic Cardiac Ablation Solutions.
NCT03012841 is a NA study of Atrial Fibrillation that has completed, run by Medtronic Cardiac Ablation Solutions. The registered enrollment target is 186 participants, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03012841, a NA study of Atrial Fibrillation, has completed, sponsored by Medtronic Cardiac Ablation Solutions.
- COMPLETED
- Registry status
- NA
- Development phase
- 186 participants
- Enrollment target
- 20
- Study locations
Study Summary
To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent atrial fibrillation (AF).
Primary Outcome
Treatment failure is defined as any of the following components: * Acute procedural failure * Documented AF/atrial tachycardia (AT)/atrial flutter (AFL) after the 90 day blanking period * A reablation for the treatment of recurrent AF/AT/AFL after the 90 day blanking period * Class I or III antiarrhythmic drug (AAD) dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new Class I or III AAD after the 90 day blanking period. * Ablation usi
Conditions Studied
Interventions
- DEVICE Arctic Front Advance Cardiac CryoAblation Catheter
Study Locations (20)
Colorado
- Colorado Heart and Vascular - Lakewood
- Medical Center of the Rockies - Loveland
Florida
- Cardiac Arrhythmia Service - Boca Raton
- Saint Vincent's Medical Center - Jacksonville
Illinois
- Northwestern University - Chicago
- NorthShore University Health System - Evanston
New York
- Icahn School of Medicine at Mount Sinai - New York
- Northwell Health (Lenox Hill Hospital and Staten Island University Hospital) - New York
Washington
- Virginia Mason Medical Center - Seattle
- Swedish Medical Center - Seattle
Arizona
- Banner-University Medical Center Phoenix - Phoenix
Maryland
- The Johns Hopkins Hospital - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2017-03-02 |
| Est. Completion | 2019-08-13 |
| Phase | NA |
What the finished NCT03012841 record still lists
NCT03012841 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which Arctic Front Advance Cardiac CryoAblation Catheter is the first listed.
NCT03012841 names 20 study sites across 15 states, led by Colorado, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03012841 about?
NCT03012841 is a clinical study titled "STOP Persistent AF". To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent atrial fibrillation (AF).
What is the current status of trial NCT03012841?
This trial is currently completed. It is a NA study. The enrollment target is 186 participants. The study started on 2017-03-02. Estimated completion is 2019-08-13.
What conditions does trial NCT03012841 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT03012841?
The interventions under investigation include: Arctic Front Advance Cardiac CryoAblation Catheter (DEVICE).
Who is sponsoring clinical trial NCT03012841?
This trial is sponsored by Medtronic Cardiac Ablation Solutions, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03012841 being conducted?
This trial has 20 study locations across Arizona, Colorado, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03012841's enrollment target sits among peer trials
186 108th of 202 higher than 95 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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