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NCT02498769 · ClinicalTrials.gov registry record · Phase 1
Temporary Autonomic Blockade to Prevent Atrial Fibrillation After Cardiac Surgery
A Phase 1 study of Atrial Fibrillation, sponsored by Joseph Mathew, M.D..
- Completed
- Registry status
- Phase 1
- Development phase
- 130
- Enrollment target
- 1
- Study location
NCT02498769 is a Phase 1 study of Atrial Fibrillation that has completed, run by Joseph Mathew, M.D.. The registered enrollment target is 130 participants, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02498769, a Phase 1 study of Atrial Fibrillation, has completed, sponsored by Joseph Mathew, M.D..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 130 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, the investigators aim to determine whether injecting botulinum toxin into epicardial fat pads is efficacious and safe for decreasing postoperative atrial fibrillation (POAF) after cardiac surgery. The investigators will test the hypothesis that botulinum toxin injected into the epicardial fat pads reduces POAF and length of stay (LOS) without increasing adverse events. This will be a prospective randomized trial of 130 patients undergoing coronary artery bypass graft (CABG), valve surgery or CABG + valve surgery with cardiopulmonary bypass. Patients will be randomized to receive either botulinum toxin (50 units per fat pad, n=65) or normal saline/placebo (1 mL per fat pad, n=65) injected into epicardial fat pads. All patients will receive standardized anesthetic, surgical, and post-surgical care. The primary outcome in this study will be time to occurrence of in-hospital POAF. Based on previous work and a pilot trial showing a pronounced reduction (relative risk reduction 77%) in POAF after injecting botulinum into the epicardial fat pads, the investigators anticipate a significant reduction in the risk for POAF with epicardial botulinum in this cohort, which includes valve surgery patients.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Botulinum Toxin Type A
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2015-09 |
| Est. Completion | 2018-12-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02498769
The ClinicalTrials.gov registry entry for NCT02498769 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (96% lower). The listed sponsor is Joseph Mathew, M.D., which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02498769 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT02498769 about?
NCT02498769 is a clinical study titled "Temporary Autonomic Blockade to Prevent Atrial Fibrillation After Cardiac Surgery". In this study, the investigators aim to determine whether injecting botulinum toxin into epicardial fat pads is efficacious and safe for decreasing postoperative atrial fibrillation (POAF) after cardiac surgery. The investigators will test the hypothesis that botulinum toxin injected into the epicar...
What is the current status of trial NCT02498769?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2015-09. Estimated completion is 2018-12-01.
What conditions does trial NCT02498769 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT02498769?
The interventions under investigation include: Placebo (DRUG), Botulinum Toxin Type A (DRUG).
Who is sponsoring clinical trial NCT02498769?
This trial is sponsored by Joseph Mathew, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02498769 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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