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NCT02132767 · ClinicalTrials.gov registry record · Phase 3
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
A Phase 3 study of Post Operative Atrial Fibrillation, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 3
- Development phase
- 523
- Enrollment target
- 20
- Study locations
NCT02132767: Completed Phase 3 study of Post Operative Atrial Fibrillation, sponsored by Icahn School of Medicine at Mount Sinai.
NCT02132767 is a Phase 3 study of Post Operative Atrial Fibrillation that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 523 participants, roughly in line with the 481-participant average among 5 other Post Operative Atrial Fibrillation trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02132767, a Phase 3 study of Post Operative Atrial Fibrillation, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 523 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in hospital within 60 days of the occurrence of AF compared to a strategy of rate control.
Primary Outcome
The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.
Conditions Studied
Interventions
- DRUG Amiodarone
- PROCEDURE DC-cardioversion
- DRUG Rate Control
Study Locations (20)
New York
- Icahn School of Medicine at Mount Sinai - New York
- Columbia University Medical Center - New York
- Montefiore Einstein Heart Center - The Bronx
Maryland
- University of Maryland - Baltimore
- NIH Heart Center at Suburban Hospital - Bethesda
North Carolina
- Mission Hospital - Asheville
- Duke University - Durham
Ohio
- Cleveland Clinic Foundation - Cleveland
- The Ohio State University Medical Center - Columbus
Texas
- Baylor College of Medicine - Houston
- Baylor Research Institute - Plano
California
- University of Southern California - Los Angeles
Georgia
- Emory University - Atlanta
Michigan
- University of Michigan Health Services - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 523 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-09 |
| Phase | Phase 3 |
What the finished NCT02132767 record still lists
NCT02132767 is an interventional study that assigns participants to a tested intervention. The registered 523 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 481-participant average among 5 other Post Operative Atrial Fibrillation trials with a reported enrollment target.
The record links to 1 condition, with Post Operative Atrial Fibrillation appearing as the primary indexed condition, and to 3 interventions - of which Amiodarone is the first listed.
NCT02132767 names 20 study sites across 14 states, led by New York, Maryland, North Carolina.
Frequently Asked Questions
What is clinical trial NCT02132767 about?
NCT02132767 is a clinical study titled "Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation". The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after cardiac surgery, the hypothes...
What is the current status of trial NCT02132767?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 523 participants. The study started on 2014-05. Estimated completion is 2015-09.
What conditions does trial NCT02132767 study?
This clinical trial studies the following conditions: Post Operative Atrial Fibrillation.
What interventions are being tested in trial NCT02132767?
The interventions under investigation include: Amiodarone (DRUG), DC-cardioversion (PROCEDURE), Rate Control (DRUG).
Who is sponsoring clinical trial NCT02132767?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02132767 being conducted?
This trial has 20 study locations across California, Georgia, Maryland, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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