Hemodynamic Characterisation of Patients Undergoing Transcatheter Tricuspid Valve Edge-to-edge Repair in Patients With Severe Tricuspid Regurgitation and Heart Failure With Preserved Ejection Fraction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congestive Heart Failure
- Sponsor
- Heart Center Leipzig - University Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Periprocedural change in enddiastolic pressure volume relationship of the left ventricle
- Last Updated
- 5 years ago
Overview
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 tricuspid regurgitation. Changes in right- and left-ventricular function as well as the interventricular dependence will be analysed on a multimodal basis including pressure-volume loop analysis and cardiac magnetic resonance imaging.
Investigators
Philipp Lurz
Professor, Managing Senior Physician
Heart Center Leipzig - University Hospital
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Periprocedural change in enddiastolic pressure volume relationship of the left ventricle
Time Frame: Periprocedural.
Change in the ratio of pressure to volume of the left ventricle before and after TTVR. Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.
Secondary Outcomes
- Change in the ratio of isovolumetric relaxation constant "Tau" and duration of diastole of the left ventricle.(Periprocedural.)
- Change in dPdtmin(Periprocedural.)
- Change in the estimated left ventricular end diastolic volume at 10 mmHg as estimated by the left ventricular pressure volume relationship (LVEDPVR)(Periprocedural.)
- Change in the early diastolic filling pattern as assessed by MRI.(Baseline and 1-month follow-up following TTVR.)