Status:
NOT_YET_RECRUITING
Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
California Table Grape Commission
Conditions:
Post-operative Atrial Fibrillation (POAF)
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
PHASE2
Brief Summary
Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery and leads to worse outcomes. POAF is thought to be caused by the inflammatory state following cardiac surger...
Detailed Description
Voluntary recruitment hold pending approval of new protocol.
Eligibility Criteria
Inclusion
- Males and female patients (age 50-79) at the Mitral Valve Clinic/CVC undergoing elective cardiac surgery for mitral valve repair without the Cox MAZE procedure (MVR patients also undergoing CABG and/or tricuspid valve repair are also eligible)
- In sinus rhythm (no pre-operative atrial fibrillation)
Exclusion
- Age ≥ 80 years
- Diagnosed pre-operative chronic or paroxysmal AF
- Prior ablation procedure for AF
- Previous cardiac surgery
- Implanted pacemaker
- Active smoker
- Comorbidities such as congenital or cardiac re-operation
- Use of antiarrhythmic agents
- Active inflammatory or infectious disease or malignancy
- Diagnosed autoimmune disease
- Corticosteroid or other immunomodulatory or immunosuppressive medication
- Risk factors for POAF including low ejection fraction (EF) (EF\<50%), left atrial (LA) dilation (LA\>5.0 cm), and high degree of mitral regurgitation (grade 3-4).
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05991700
Start Date
September 1 2025
End Date
January 1 2027
Last Update
July 14 2025
Active Locations (1)
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1
University of Michigan - Michigan Medicine
Ann Arbor, Michigan, United States, 48109