Impact of valve positioning on heart function after TAVR
Transcatheter Aortic Valve Implantation (TAVR): The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics
This study is testing how the placement of a new heart valve during TAVR affects blood flow and heart function to see if certain imaging methods can replace the current standard for checking valve alignment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Düsseldorf) |
| Trial ID | NCT06896227 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates how the positioning of transcatheter aortic valve replacement (TAVR) prostheses affects blood flow dynamics and coronary artery function. It aims to determine if cardiac magnetic resonance imaging and echocardiography can serve as effective alternatives to the current standard of care, which is computer tomography, for assessing commissural alignment. The study will also explore the influence of valve positioning on coronary flow and overall hemodynamics post-TAVR. By focusing on these aspects, the research seeks to enhance long-term management strategies for patients undergoing TAVR.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have undergone transfemoral transcatheter aortic valve replacement.
Not a fit: Patients who have had valve-in-valve procedures or those with certain medical conditions that impair informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and longevity for patients receiving TAVR by optimizing valve positioning.
How similar studies have performed: While there have been studies on TAVR, this specific focus on valve positioning and its hemodynamic effects is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria \- Patients who have undergone transfemoral transcatheter aortic valve replacement (TAVR). Exclusion Criteria * Any access route other than transfemoral. * Valve-in-valve procedures. * History of prior bioprosthetic valve implantation. * Presence of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) system. * Diagnosis of liver cirrhosis. * Esophageal disorders, including but not limited to esophageal varices. * Thrombocytopenia or coagulation disorders. * Any medical or psychiatric condition (e.g., dementia, alcoholism, or substance abuse) that may impair the ability to provide informed consent or interfere with study procedures, including follow-up visits.
Where this trial is running
Düsseldorf
- Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf — Düsseldorf, Germany (Recruiting)
Study contacts
- Study coordinator: Tobias Zeus, Prof
- Email: zeus@med.uni-duesseldorf.de
- Phone: 0211 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.