Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients (HERACLES-HFpEF)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Congestive Heart Failure; Tricuspid Regurgitation
• Intervention / Treatment: Device: Transcatheter tricuspid valve edge-to-edge repair

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karl-Patrik Kresoja, MD; Phone Number: 0341865252596; Email: karl-patrik.kresoja@medizin.uni-leipzig.de
• Study Contact Backup: Name: Philipp Lurz, MD, PhD; Phone Number: 0341865252529; Email: philipp.lurz@medizin.uni-leipzig.de

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Recruiting
      • Heart Centre at University Leipzig
      • Contact: Philipp Lurz, MD, PhD; Phone Number: 0341 865 252529; Email: philipp.lurz@medizin.uni-leipzig.de
      • Sub-Investigator: Matthias Unterhuber, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Transcatheter tricuspid valve edge-to-edge repair; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Heart Center Leipzig - University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): March 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Heart failure with preserved ejection fraction; tricuspid regurgitation; transcatheter tricuspid valve edge-to-edge repair
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Heart Failure; Tricuspid Valve Insufficiency
• Other Study ID Numbers: HERACLES-HFpEF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Anonymized data will be made available on reasonable cooperation request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No