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New treatment option for Post-operative Atrial Fibrillation (POAF)
Official title Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation
ClinicalTrials.gov ID: NCT05991700
What this study is testing
What is Freeze-Dried California Table Grape?
Freeze-Dried California Table Grape is an investigational medicine, being studied as a potential treatment for post-operative atrial fibrillation (poaf).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 surgery.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- 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...
- In sinus rhythm (no pre-operative atrial fibrillation)
You likely can't join if
- Age ≥ 80 years
- Diagnosed pre-operative chronic or paroxysmal AF
- Prior ablation procedure for AF
- Previous cardiac surgery
- Implanted pacemaker
- Active smoker
See the full eligibility criteria
- 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...
- In sinus rhythm (no pre-operative atrial fibrillation)
- 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\ 5.0 cm), and high degree of mitral regurgitation (grade 3-4).
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.