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Search / Trial NCT06896227

TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics

Launched by HEINRICH-HEINE UNIVERSITY, DUESSELDORF · Mar 19, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Tavr Tavi Commissural Alignment Symmetry Prothesis Positioning C Mri 4 D Flow Tee

ClinConnect Summary

This clinical trial is looking at how the positioning of a special heart valve, called a TAVR prosthesis, affects blood flow in the heart and the coronary arteries. The study aims to find out if certain imaging techniques, like cardiac MRI and echocardiography, can replace the more advanced CT scans that are currently used to check the alignment of the valve. It will also explore how the valve's position impacts blood flow and how it can affect the heart's ability to supply blood to the body after the procedure.

To participate in this trial, patients must have undergone a specific type of heart valve replacement called transfemoral TAVR. However, individuals with certain health issues, such as prior valve replacements, pacemakers, liver cirrhosis, or conditions that might affect their understanding of the study, may not be eligible. If you join the study, you can expect to have various imaging tests done to help researchers gather important information about how the valve is positioned and how it affects blood flow. This research could lead to better outcomes for patients undergoing TAVR in the future.

Gender

ALL

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.

About Heinrich Heine University, Duesseldorf

Heinrich-Heine University Düsseldorf is a leading academic institution dedicated to advancing medical research and education. Renowned for its innovative approach to healthcare and interdisciplinary collaboration, the university plays a pivotal role in clinical trials aimed at improving patient outcomes and translating scientific discoveries into clinical practice. With a robust infrastructure and a commitment to ethical standards, Heinrich-Heine University fosters an environment that supports cutting-edge research initiatives, contributing significantly to the advancement of medical knowledge and therapeutic interventions.

Locations

Duesseldorf, , Germany

Patients applied

0 patients applied

Trial Officials

Malte Kelm, Prof.

Study Chair

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Tobias Zeus, Prof.

Study Director

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Kathrin Klein, Dr. med.

Study Director

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported