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NCT03868150 · ClinicalTrials.gov registry record · Phase 4
Prevention of Postop Atrial Fibrillation Through Intraoperative Inducibility of Atrial Fibrillation and Amiodarone Treatment
A Phase 4 study of Post Operative Atrial Fibrillation, sponsored by Stanford University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 600
- Enrollment target
- 1
- Study location
NCT03868150: Recruiting Phase 4 study of Post Operative Atrial Fibrillation, sponsored by Stanford University.
NCT03868150 is a Phase 4 study of Post Operative Atrial Fibrillation that is actively recruiting participants, run by Stanford University. The registered enrollment target is 600 participants, above the 466-participant average among 5 other Post Operative Atrial Fibrillation trials with a reported enrollment target (29% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03868150, a Phase 4 study of Post Operative Atrial Fibrillation, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 600 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients undergoing first time cardiac surgery will undergo rapid atrial pacing prior to initiation of cardiopulmonary bypass to screen for AF inducibility. Patients with inducible AF will be randomized to prophylactic amiodarone treatment versus no treatment. Patients who are not inducible to AF will be treated with standard post-operative care. Patients will be monitored post-operatively to explore the value of intraoperative inducibility of AF to predict POAF and to evaluate whether the combination of intraoperative inducibility and precision amiodarone therapy is effective at reducing the incidence of POAF
Primary Outcome
Identify predictors of developing atrial fibrillation in the hope of decreasing post-operative length of stay, the need for anticoagulation, decrease risk of stroke, DVT, and bleeding
Conditions Studied
Interventions
- DRUG Amiodarone Injection
- DEVICE Intraoperative Rapid Atrial Pacing
Study Locations (1)
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2050-12-31 |
| Phase | Phase 4 |
What NCT03868150 shows while recruiting
NCT03868150 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 466-participant average among 5 other Post Operative Atrial Fibrillation trials with a reported enrollment target (29% higher).
The record links to 1 condition, with Post Operative Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Amiodarone Injection is the first listed.
NCT03868150 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03868150 about?
NCT03868150 is a clinical study titled "Prevention of Postop Atrial Fibrillation Through Intraoperative Inducibility of Atrial Fibrillation and Amiodarone Treatment". Patients undergoing first time cardiac surgery will undergo rapid atrial pacing prior to initiation of cardiopulmonary bypass to screen for AF inducibility. Patients with inducible AF will be randomized to prophylactic amiodarone treatment versus no treatment. Patients who are not inducible to AF wi...
What is the current status of trial NCT03868150?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 600 participants. The study started on 2017-03-01. Estimated completion is 2050-12-31.
What conditions does trial NCT03868150 study?
This clinical trial studies the following conditions: Post Operative Atrial Fibrillation.
What interventions are being tested in trial NCT03868150?
The interventions under investigation include: Amiodarone Injection (DRUG), Intraoperative Rapid Atrial Pacing (DEVICE).
Who is sponsoring clinical trial NCT03868150?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03868150 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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