Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients

NCT04782908 | Unknown

• 1 other identifier: HERACLES-HFpEF
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure; Tricuspid Regurgitation

Keywords

Heart failure with preserved ejection fraction; tricuspid regurgitation; transcatheter tricuspid valve edge-to-edge repair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 ratio of isovolumetric relaxation constant "Tau" and duration of diastole of the left ventricle.

  Periprocedural.

• Change in dPdtmin

  Periprocedural.

• Change in the early diastolic filling pattern as assessed by MRI.

  Baseline and 1-month follow-up following TTVR.

Study Arms (1)

Transcatheter tricuspid valve edge-to-edge repair

EXPERIMENTAL

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

Interventions

Transcatheter tricuspid valve edge-to-edge repair DEVICE

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.

Transcatheter tricuspid valve edge-to-edge repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart Center Leipzig - University Hospital: lead

Study Sites (1)

Heart Centre at University Leipzig

Leipzig, Saxony, 04289, Germany

RECRUITING

MeSH Terms

Conditions

Heart Failure; Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases

Central Study Contacts

Karl-Patrik Kresoja, MD

CONTACT

0341865252596; karl-patrik.kresoja@medizin.uni-leipzig.de

Philipp Lurz, MD, PhD

CONTACT

0341865252529; philipp.lurz@medizin.uni-leipzig.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcome assessors will be blinded whether they are analysing pre or post transcatheter tricuspid valve edge-to-edge repair data.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Managing Senior Physician

Model Details: 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

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: March 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

DE (1)