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

Heart Center Leipzig - University Hospital

Status: Unknown

Conditions: Tricuspid Regurgitation; Congestive Heart Failure

Treatments: Device: Transcatheter tricuspid valve edge-to-edge repair

Study type: Interventional

Funder types: Other

Identifiers

NCT04782908

HERACLES-HFpEF

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Transcatheter tricuspid valve edge-to-edge repair

Experimental group

Description:

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.

Treatment:

Device: Transcatheter tricuspid valve edge-to-edge repair