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NCT03604263 · ClinicalTrials.gov registry record · NA
ArcticLine Feasibility Study
A NA study of Atrial Fibrillation and Atrial Flutter, sponsored by Medtronic Cardiac Ablation Solutions.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
- 4
- Study locations
NCT03604263: Completed NA study of Atrial Fibrillation and Atrial Flutter, sponsored by Medtronic Cardiac Ablation Solutions.
NCT03604263 is a NA study of Atrial Fibrillation and Atrial Flutter that has completed, run by Medtronic Cardiac Ablation Solutions. The registered enrollment target is 17 participants, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03604263, a NA study of Atrial Fibrillation and Atrial Flutter, has completed, sponsored by Medtronic Cardiac Ablation Solutions.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of the ArcticLine Feasibility Study is to collect preliminary safety and effectiveness data on the ArcticLine Catheter.
Primary Outcome
A primary safety event is defined as: An ArcticLine Catheter-related or ArcticLine cryoablation procedure-related SAE with an onset date within 7 days post-procedure (except as noted below), as adjudicated by the Clinical Events Committee (CEC), described as follows: * Atrioesophageal fistula\* \* Includes atrioesophageal fistula with an onset date at any time after the study cryoablation procedure and is adjudicated by the CEC as either ArcticLine Catheter-related or ArcticLine cryoablatio
Conditions Studied
Interventions
- DEVICE ArcticLine Cardiac Cryoablation Catheter
Study Locations (4)
Florida
- BayCare Medical Group Cardiology - Tampa
Michigan
- University of Michigan - Ann Arbor
Pennsylvania
- University of Pittsburgh Medical Center (UPMC) - Pittsburgh
Quebec
- Montreal Heart Institute - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-10-18 |
| Est. Completion | 2019-11-18 |
| Phase | NA |
What the finished NCT03604263 record still lists
NCT03604263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which ArcticLine Cardiac Cryoablation Catheter is the first listed.
NCT03604263 reports a single indexed study location in Florida, Michigan, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03604263 about?
NCT03604263 is a clinical study titled "ArcticLine Feasibility Study". The purpose of the ArcticLine Feasibility Study is to collect preliminary safety and effectiveness data on the ArcticLine Catheter.
What is the current status of trial NCT03604263?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2018-10-18. Estimated completion is 2019-11-18.
What conditions does trial NCT03604263 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Atrial Flutter.
What interventions are being tested in trial NCT03604263?
The interventions under investigation include: ArcticLine Cardiac Cryoablation Catheter (DEVICE).
Who is sponsoring clinical trial NCT03604263?
This trial is sponsored by Medtronic Cardiac Ablation Solutions, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03604263 being conducted?
This trial has 4 study locations across Florida, Michigan, Pennsylvania, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03604263's enrollment target sits among peer trials
17 195th of 202 higher than 7 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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