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NCT03546374 · ClinicalTrials.gov registry record · NA
Medtronic Terminate AF Study
A NA study of Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, sponsored by Medtronic Cardiac Surgery.
- Recruiting
- Registry status
- NA
- Development phase
- 160
- Enrollment target
- 15
- Study locations
NCT03546374: Recruiting NA study of Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, sponsored by Medtronic Cardiac Surgery.
NCT03546374 is a NA study of Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation that is actively recruiting participants, run by Medtronic Cardiac Surgery. The registered enrollment target is 160 participants, below the 1,250-participant average among 15 other Persistent Atrial Fibrillation trials with a reported enrollment target (87% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03546374, a NA study of Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, is actively recruiting participants, sponsored by Medtronic Cardiac Surgery.
- RECRUITING
- Registry status
- NA
- Development phase
- 160 participants
- Enrollment target
- 15
- Study locations
Study Summary
The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).
Primary Outcome
Composite acute major adverse event rate including: Atrial tears, Esophageal injury, Excessive bleeding, Mediastinitis, Myocardial infarction (MI), Pulmonary embolism, Peripheral arterial embolism, Stroke, Transient ischemic attacks (TIA), Death.
Conditions Studied
Interventions
- PROCEDURE Surgical Ablation
- DEVICE Cardioblate and Cryoflex hand held devices
Study Locations (15)
Washington
- Virginia Mason Heart Institute - Seattle
- Swedish Medical Center - Seattle
- St. Joseph Medical Center - Tacoma
California
- Stanford Hospitals and Clinic - Palo Alto
- Adventist Health St. Helena - St. Helena
Pennsylvania
- Allegheny General Hospital - Pittsburgh
- Lankenau Medical Center - Wynnewood
Connecticut
- Hartford Healthcare - Hartford
Indiana
- St Vincent Heart Center of Indiana - Indianapolis
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Corewell Health - Grand Rapids
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2018-11-15 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT03546374 shows while recruiting
NCT03546374 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 1,250-participant average among 15 other Persistent Atrial Fibrillation trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Persistent Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Surgical Ablation is the first listed.
NCT03546374 lists 15 locations in 11 states (Washington, California, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT03546374 about?
NCT03546374 is a clinical study titled "Medtronic Terminate AF Study". The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).
What is the current status of trial NCT03546374?
This trial is currently recruiting. It is a NA study. The enrollment target is 160 participants. The study started on 2018-11-15. Estimated completion is 2026-12.
What conditions does trial NCT03546374 study?
This clinical trial studies the following conditions: Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation.
What interventions are being tested in trial NCT03546374?
The interventions under investigation include: Surgical Ablation (PROCEDURE), Cardioblate and Cryoflex hand held devices (DEVICE).
Who is sponsoring clinical trial NCT03546374?
This trial is sponsored by Medtronic Cardiac Surgery, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03546374 being conducted?
This trial has 15 study locations across California, Connecticut, Indiana, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03546374's enrollment target sits among peer trials
160 12th of 15 higher than 4 of 15 other Persistent Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Persistent 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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