Status:
RECRUITING
TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Conditions:
Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Implantation
Eligibility:
All Genders
Phase:
NA
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 card...
Detailed Description
Coming from a treatment option only for a high-risk cohort of elderly patients, transcatheter aortic valve replacement (TAVR) has become a safe and effective therapeutic approach for most patients wit...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06896227
Start Date
October 22 2024
End Date
December 31 2025
Last Update
March 26 2025
Active Locations (1)
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1
Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
Düsseldorf, Germany, 40225