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NCT03118518 · ClinicalTrials.gov registry record · NA
STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation
A NA study of Atrial Fibrillation and Atrial Fibrillation New Onset, sponsored by Medtronic Cardiac Ablation Solutions.
- Completed
- Registry status
- NA
- Development phase
- 225
- Enrollment target
- 20
- Study locations
NCT03118518: Completed NA study of Atrial Fibrillation and Atrial Fibrillation New Onset, sponsored by Medtronic Cardiac Ablation Solutions.
NCT03118518 is a NA study of Atrial Fibrillation and Atrial Fibrillation New Onset that has completed, run by Medtronic Cardiac Ablation Solutions. The registered enrollment target is 225 participants, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03118518, a NA study of Atrial Fibrillation and Atrial Fibrillation New Onset, has completed, sponsored by Medtronic Cardiac Ablation Solutions.
- COMPLETED
- Registry status
- NA
- Development phase
- 225 participants
- Enrollment target
- 20
- Study locations
Study Summary
To provide data demonstrating the safety and effectiveness of the Arctic Front Advance™ Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal atrial fibrillation, without the requirement that the subjects be drug refractory.
Primary Outcome
Treatment success after AAD initiation (control arm) or pulmonary vein isolation ablation procedure utilizing the Arctic Front Advance™ Cardiac CryoAblation Catheter (treatment arm). Treatment success is the opposite of treatment failure. Treatment failure was defined as any of the following: * Acute procedural failure (treatment arm only). * Documented AF/AT/AFL on ambulatory monitoring/12-lead ECG after the 90-day post-ablation blanking period (treatment)/AAD optimization period (control arm)
Conditions Studied
Interventions
- DEVICE Cryoablation
- DRUG Antiarrhythmic drug
Study Locations (20)
Florida
- Tallahassee Research Institute Inc - Tallahassee
- BayCare Medical Group Cardiology - Tampa
Michigan
- University of Michigan Health System - University Hospital - Ann Arbor
- Spectrum Health Hospitals - Grand Rapids
New Jersey
- Hackensack University Medical Center - Hackensack
- The Valley Hospital - Ridgewood
Ohio
- Cleveland Clinic - Cleveland
- Ohio State University - Columbus
Alabama
- Grandview Medical Center - Birmingham
Alaska
- Alaska Heart Institute - Anchorage
California
- Hoag Hospital Newport Beach - Newport Beach
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2017-06-23 |
| Est. Completion | 2020-06-25 |
| Phase | NA |
What the finished NCT03118518 record still lists
NCT03118518 is an interventional study that assigns participants to a tested intervention. The registered 225 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 (92% lower).
The record links to 2 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Cryoablation is the first listed.
NCT03118518 names 20 study sites across 16 states, led by Florida, Michigan, New Jersey.
Frequently Asked Questions
What is clinical trial NCT03118518 about?
NCT03118518 is a clinical study titled "STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation". To provide data demonstrating the safety and effectiveness of the Arctic Front Advance™ Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal atrial fibrillation, without the requirement that the subjects be drug refractory.
What is the current status of trial NCT03118518?
This trial is currently completed. It is a NA study. The enrollment target is 225 participants. The study started on 2017-06-23. Estimated completion is 2020-06-25.
What conditions does trial NCT03118518 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Atrial Fibrillation New Onset.
What interventions are being tested in trial NCT03118518?
The interventions under investigation include: Cryoablation (DEVICE), Antiarrhythmic drug (DRUG).
Who is sponsoring clinical trial NCT03118518?
This trial is sponsored by Medtronic Cardiac Ablation Solutions, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03118518 being conducted?
This trial has 20 study locations across Alabama, Alaska, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03118518's enrollment target sits among peer trials
225 95th of 202 higher than 107 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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