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NCT05780320 · ClinicalTrials.gov registry record
A Pharmaco-surgical Approach to Reduce Postoperative Atrial Fibrillation After Cardiac Surgery
A clinical trial, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 242
- Enrollment target
NCT05780320: Completed study, sponsored by Massachusetts General Hospital.
NCT05780320 is a clinical trial that has completed, run by Massachusetts General Hospital. The registered enrollment target is 242 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05780320 has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 242 participants
- Enrollment target
Study Summary
Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery with an estimated incidence around 35%. It has been found to be an independent predictor of 30-day and 6-month mortality, stroke, renal failure, respiratory failure, and need for permanent pacemaker among others. Previous studies including meta-analyses demonstrate a protective benefit of prophylactic amiodarone to decrease the risk of POAF. However, this has not been widely adopted, and recent society guidelines only give prophylactic amiodarone a Class IIA recommendation, citing risk of amiodarone-related toxicity and hypotension as reasons for the Class IIA recommendation. A meta-analysis comparing cumulative doses of amiodarone found that moderate to higher doses of amiodarone have a marginally increased benefit in reducing the incidence of postoperative atrial fibrillation over lower doses; however, the study did not assess risk of complications stratified by cumulative doses, which has been previously described. Finally, a recent meta-analysis showed that a posterior pericardiotomy was highly effective at reducing postoperative atrial fibrillation. Consequently, the investigators' institution has adopted a pharmaco-surgical approach (prophylactic amiodarone and posterior pericardiotomy) in an effort to reduce postoperative atrial fibrillation after coronary artery bypass cardiac surgery for all patients who meet inclusion/exclusion criteria.
Interventions
- OTHER Prophylactic amiodarone and posterior pericardiotomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2022-09-19 |
| Est. Completion | 2025-03-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05780320
The ClinicalTrials.gov registry entry for NCT05780320 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 242 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Prophylactic amiodarone and posterior pericardiotomy is the first listed.
NCT05780320 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05780320 about?
NCT05780320 is a clinical study titled "A Pharmaco-surgical Approach to Reduce Postoperative Atrial Fibrillation After Cardiac Surgery". Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery with an estimated incidence around 35%. It has been found to be an independent predictor of 30-day and 6-month mortality, stroke, renal failure, respiratory failure, and need for permanent pacemaker among oth...
What is the current status of trial NCT05780320?
This trial is currently completed. The enrollment target is 242 participants. The study started on 2022-09-19. Estimated completion is 2025-03-15.
What interventions are being tested in trial NCT05780320?
The interventions under investigation include: Prophylactic amiodarone and posterior pericardiotomy (OTHER).
Who is sponsoring clinical trial NCT05780320?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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