Status:
UNKNOWN
Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients
Lead Sponsor:
Heart Center Leipzig - University Hospital
Conditions:
Congestive Heart Failure
Tricuspid Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the study is to investigate the pathophysiological implications of transcatheter tricuspid valve edge-to-edge repair in patient with heart failure and preserved ejection fraction and severe...
Eligibility Criteria
Inclusion
- Severe tricuspid regurgitation with need for interventional treatment approach as decided by an interdisciplinary heart team.
- Signs and symptoms of left-sided heart failure.
- Left-ventricular ejection fraction ≥50%
- Invasive evidence of elevated left-ventricular fillings pressures (pulmonary capillary wedge pressure \[PCWP\] or left-ventricular end-diastolic pressure ≥15 mmHg)
Exclusion
- Concomitant relevant mitral valve regurgitation with need for concomitant interventional treatment
- Moderate aortic stenosis.
- Pregnancy
- Contraindication to perform cardiac magnetic resonance imaging.
- Conditions rendering patient unable to give informed consent to the study protocol.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04782908
Start Date
March 1 2021
End Date
June 30 2022
Last Update
April 19 2021
Active Locations (1)
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1
Heart Centre at University Leipzig
Leipzig, Saxony, Germany, 04289