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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03118518
The ClinicalTrials.gov registry entry for NCT03118518 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (92% lower). The listed sponsor is Medtronic Cardiac Ablation Solutions, which has 20 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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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