NCT06896227 TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics
| NCT ID | NCT06896227 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heinrich-Heine University, Duesseldorf |
| Condition | Transcatheter Aortic Valve Replacement |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-10-22 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this clinical study is to learn more about the effects of TAVR-prosthesis positioning on hemodynamics and the coronary arteries. The main questions it aims to answer are: 1. Does the cardiac magnetic resonance imaging and the echocardiography imaging provide an equivalent alternative to the computer tomography which is the state of the art in evaluating commissural alignment? 2. What effect does the position of the valve on the annular level have, especially its symmetrical and commissural position, on valvular and aortic blood flow characteristics? 3. What is the influence of symmetrical position and the presence of a commissural alignment on the coronary flow after transcatheter aortic valve replacement?
Eligibility 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.
Contact & Investigator
Malte Kelm, Prof.
STUDY CHAIR
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Frequently Asked Questions
Who can join the NCT06896227 clinical trial?
This trial is open to participants of all sexes, studying Transcatheter Aortic Valve Replacement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06896227 currently recruiting?
Yes, NCT06896227 is actively recruiting participants. Contact the research team at zeus@med.uni-duesseldorf.de for enrollment information.
Where is the NCT06896227 trial being conducted?
This trial is being conducted at Düsseldorf, Germany.
Who is sponsoring the NCT06896227 clinical trial?
NCT06896227 is sponsored by Heinrich-Heine University, Duesseldorf. The principal investigator is Malte Kelm, Prof. at Division of Cardiology, Pulmonary Disease and Vascular Medicine. The trial plans to enroll 100 participants.