Evaluating and treating blood clots in heart valve replacements
Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Dysfunction With Multimodality Imaging and Its TrEatment With Anticoagulation
This study is testing if advanced imaging can help find and treat blood clots in patients with bioprosthetic aortic valves to improve their health after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT02318342 on ClinicalTrials.gov |
What this trial studies
This study assesses the structural and functional integrity of bioprosthetic aortic valves using advanced imaging techniques, including cardiac contrast CT and transthoracic echocardiography. Patients who have undergone bioprosthetic valve replacement will be monitored for thrombotic changes, and those with abnormalities will receive anticoagulation therapy. Follow-up imaging will be conducted after three months to evaluate the effectiveness of the treatment. The goal is to confirm the resolution of thrombotic changes and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have received a bioprosthetic aortic valve at least 48 hours prior to enrollment.
Not a fit: Patients with renal insufficiency or known allergies to iodinated contrast agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of prosthetic valve thrombosis, leading to better patient outcomes and reduced complications.
How similar studies have performed: Other studies have shown promise in managing prosthetic valve thrombosis with anticoagulation, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Presence of transcatheter or surgical bioprosthetic aortic valve implanted at least 48 hours prior to enrollment * Age 18 years or older * Ability to provide informed consent and follow-up with protocol procedures. Exclusion Criteria: * Renal insufficiency (creatinine \> 1.5 mg/dL) * Known allergy to iodinated contrast agents
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Raj Makkar, MD — Cedars-Sinai Medical Center, Los Angeles, California
- Study coordinator: Tarun Chakravarty, MD
- Email: tarunchakravarty@gmail.com
- Phone: 3104233977
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.