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NCT00889681 · ClinicalTrials.gov registry record · NA
Continued Access Protocol
A NA study of Atrial Fibrillation, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- NA
- Development phase
- 81
- Enrollment target
- 10
- Study locations
NCT00889681: Completed NA study of Atrial Fibrillation, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT00889681 is a NA study of Atrial Fibrillation that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 81 participants, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (97% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00889681, a NA study of Atrial Fibrillation, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- NA
- Development phase
- 81 participants
- Enrollment target
- 10
- Study locations
Study Summary
This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review. This study will also allow collection of additional safety data following modifications implemented into the Arctic Front® Catheter and Cryoablation System.
Primary Outcome
Composite event: access site complications, cardiac damage (including myocardial infarction), embolic phenomena (including stroke), arrhythmia, persistent phrenic nerve injury, death and pulmonary vein stenosis.
Conditions Studied
Interventions
- DEVICE Arctic Front Cardiac Cryoablation System
Study Locations (10)
California
- Cedars Sinai Medical Center - Los Angeles
- Stanford Hospital & Clinical - Stanford
Virginia
- Inova Research Center - Falls Church
- Virginia Commonwealth University Health System - Richmond
Arizona
- Banner Good Samaritan - Phoenix
Florida
- Bay Heart Group - Tampa
Georgia
- Piedmont Hospital - Atlanta
Massachusetts
- Massachusetts General Hospital - Boston
Minnesota
- Mayo Clinic - Rochester
Texas
- Baylor Heart & Vascular Hospital - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2009-03 |
| Est. Completion | 2013-10 |
| Phase | NA |
What the finished NCT00889681 record still lists
NCT00889681 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which Arctic Front Cardiac Cryoablation System is the first listed.
NCT00889681 lists 10 locations in 8 states (California, Virginia, Arizona).
Frequently Asked Questions
What is clinical trial NCT00889681 about?
NCT00889681 is a clinical study titled "Continued Access Protocol". This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review. This study will also allow collection of additional safety data following modifications ...
What is the current status of trial NCT00889681?
This trial is currently completed. It is a NA study. The enrollment target is 81 participants. The study started on 2009-03. Estimated completion is 2013-10.
What conditions does trial NCT00889681 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT00889681?
The interventions under investigation include: Arctic Front Cardiac Cryoablation System (DEVICE).
Who is sponsoring clinical trial NCT00889681?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00889681 being conducted?
This trial has 10 study locations across Arizona, California, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00889681's enrollment target sits among peer trials
81 152nd of 202 higher than 51 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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