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NCT04198701 · ClinicalTrials.gov registry record · NA
Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF
A NA study of Atrial Fibrillation, sponsored by Medtronic Cardiac Ablation Solutions.
- Completed
- Registry status
- NA
- Development phase
- 421
- Enrollment target
- 20
- Study locations
NCT04198701: Completed NA study of Atrial Fibrillation, sponsored by Medtronic Cardiac Ablation Solutions.
NCT04198701 is a NA study of Atrial Fibrillation that has completed, run by Medtronic Cardiac Ablation Solutions. The registered enrollment target is 421 participants, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04198701, a NA study of Atrial Fibrillation, has completed, sponsored by Medtronic Cardiac Ablation Solutions.
- COMPLETED
- Registry status
- NA
- Development phase
- 421 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for the treatment of atrial fibrillation (AF). The study will also provide first in human insights into clinical safety and device function of the PulseSelect PFA System for pulmonary vein isolation (PVI) as a treatment for AF. To this end, the clinical study has been designed into phases (Pilot and Pivotal), with each phase comprising a separate data set that will be analyzed and reported on per the below objectives.
Primary Outcome
Primary safety events are: Within 6 months post-ablation: * Pulmonary vein stenosis (≥70% diameter reduction) * Phrenic nerve injury/diaphragmatic paralysis (ongoing at 6 months) * Atrioesophageal fistula Within 30 days of ablation procedure: * Cardiac tamponade/perforation * Cerebrovascular accident * Major bleeding requiring transfusion * Myocardial infarction * Pericarditis requiring intervention * Transient ischemic attack * Vagal nerve injury resulting in esophageal dysmotility or gastr
Conditions Studied
Interventions
- DEVICE Medtronic PulseSelect Pulsed Field Ablation (PFA) System
Study Locations (20)
New York
- Northwell Health - North Shore University Hospital - Manhasset
- NYU Langone Health - Heart Rhythm Center - New York
- Montefiore Medical Center - The Bronx
Michigan
- Spectrum Health - Grand Rapids
- Beaumont Hospital - Royal Oak
Ohio
- Cleveland Clinic - Cleveland
- The Ohio State University Wexner Medical Center - Columbus
Alabama
- Grandview Medical Center - Birmingham
Colorado
- Medical Center of the Rockies - Loveland
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Florida
- BayCare Saint Joseph's Hospital - Tampa
Georgia
- Emory Saint Joseph's Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 421 participants |
| Start Date | 2019-12-10 |
| Est. Completion | 2022-11-28 |
| Phase | NA |
What the finished NCT04198701 record still lists
NCT04198701 is an interventional study that assigns participants to a tested intervention. The registered 421 participants enrollment target is mid-sized for trials with a published cap, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which Medtronic PulseSelect Pulsed Field Ablation (PFA) System is the first listed.
NCT04198701 names 20 study sites across 16 states, led by New York, Michigan, Ohio.
Frequently Asked Questions
What is clinical trial NCT04198701 about?
NCT04198701 is a clinical study titled "Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF". The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for the treatment of atrial fibrillation (AF). The study will also provide fi...
What is the current status of trial NCT04198701?
This trial is currently completed. It is a NA study. The enrollment target is 421 participants. The study started on 2019-12-10. Estimated completion is 2022-11-28.
What conditions does trial NCT04198701 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT04198701?
The interventions under investigation include: Medtronic PulseSelect Pulsed Field Ablation (PFA) System (DEVICE).
Who is sponsoring clinical trial NCT04198701?
This trial is sponsored by Medtronic Cardiac Ablation Solutions, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04198701 being conducted?
This trial has 20 study locations across Alabama, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04198701's enrollment target sits among peer trials
421 68th of 202 higher than 135 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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