Comparing imaging methods before heart valve replacement
Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation (TAVI)
This study is testing different imaging methods to see which one works best for measuring the aortic root in patients with aortic valve stenosis before they get a heart valve replacement.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Locations | 1 site (Düsseldorf, North Rhine-Westphalia) |
| Trial ID | NCT01805739 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate various imaging modalities used for measuring the aortic root prior to transcatheter aortic valve implantation (TAVI) in patients with aortic valve stenosis. It involves both retrospective and prospective data collection, assessing imaging techniques such as CT, MRI, angiography, and echocardiography to determine the best approach for selecting the appropriate valve prosthesis. The imaging will be performed with contrast injections into the aorta or left ventricle, and the results will be analyzed by blinded observers to ensure objectivity.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with aortic valve stenosis who are being evaluated for TAVI.
Not a fit: Patients who are unconscious or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of valve selection and reduce complications associated with TAVI procedures.
How similar studies have performed: Other studies have shown promising results in optimizing imaging techniques for TAVI, indicating that this approach is both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * aortic valve stenosis * screened for TAVI * written informed consent Exclusion Criteria: * unconsciousness, not able to consent
Where this trial is running
Düsseldorf, North Rhine-Westphalia
- Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf — Düsseldorf, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Study coordinator: Malte Kelm, MD
- Email: CTSU@med.uni-duesseldorf.de
- Phone: 0049 211 81 18800
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.