Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Congestive Heart Failure, Tricuspid Regurgitation

Intervention / Treatment
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* Device: Transcatheter tricuspid valve edge-to-edge repair


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Patients undergoing transcatheter tricuspid valve edge-to-edge repair will undergo multimodal cardiovascular diagnostics before and after tricuspid valve repair including pressure volume loop analysis and cardiac magnetic resonance imaging
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcatheter tricuspid valve edge-to-edge repair<br>Patients will undergo transcatheter tricuspid valve edge-to-edge repair (TTVR) and hemodynamic characteristics will be analysed on a multimodal approach using cardiac magnetic resonance imaging and pressure volume loop analysis before and after TTVR. | Device: Transcatheter tricuspid valve edge-to-edge repair<br>* Transcatheter tricuspid valve edge-to-edge repair is an interventional approach to treat severe tricuspid regurgitation. Under general anesthesia a clip delivery system is forwarded through the vena femoralis and right atrium in the right ventricle. A clip is deployed to clamp the tricuspid valve and reduce tricuspid valve regurgitation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periprocedural change in enddiastolic pressure volume relationship of the left ventricle | 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. | Periprocedural. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the estimated left ventricular end diastolic volume at 10 mmHg as estimated by the left ventricular pressure volume relationship (LVEDPVR) | 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. | Periprocedural. | 
| Change in the ratio of isovolumetric relaxation constant Tau and duration of diastole of the left ventricle. | 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. | Periprocedural. | 
| Change in dPdtmin | 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. | Periprocedural. | 
| Change in the early diastolic filling pattern as assessed by MRI. | All patients will receive MRI before and 1-month after TTVR on a 1.5 tesla scanner. | Baseline and 1-month follow-up following TTVR. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure with preserved ejection fraction, tricuspid regurgitation, transcatheter tricuspid valve edge-to-edge repair