Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients

Not Applicable

• Conditions: Congestive Heart Failure; Tricuspid Regurgitation
• Interventions: Device: Transcatheter tricuspid valve edge-to-edge repair

• Registration Number: NCT04782908
• Lead Sponsor: Heart Center Leipzig - University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-19
• Primary Completion: 2022-03-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcatheter tricuspid valve edge-to-edge repair	Transcatheter tricuspid valve edge-to-edge repair	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.

Primary Outcome Measures

Name	Time	Method
Periprocedural change in enddiastolic pressure volume relationship of the left ventricle	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 Outcome Measures

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

Trial Locations

Locations (1)

Heart Centre at University Leipzig; 🇩🇪 Leipzig, Saxony, Germany