Tricuspid Cardiopulmonary Exercise Study (TRCPET)

Heart and Diabetes Center North-Rhine Westfalia

Status

Completed

Conditions

Tricuspid Regurgitation

Treatments

Diagnostic Test: Cardiopulmonary Exercise Testing

Study type

Interventional

Funder types

Other

Identifiers

NCT04559256

HDZ-KA_018_MG

Details and patient eligibility

About

Tricuspid regurgitation (TR), which in close to 90% of cases is functional as a consequence of left-sided heart failure, left heart valve abnormalities or pulmonary (vascular) disease, is associated with adverse patient outcomes . Due to the increased risk of surgical tricuspid valve repair or replacement compared to surgery in left-sided valve disease TR is often undertreated. Treatment options for the tricuspid valve have so far been limited. Conservative therapy over longer. periods usually results in refractoriness to diuretic treatment. Surgical therapy is associated with a high rate of in-hospital mortality (8.8%), the cause of which is not yet fully understood but may partly be explained by the hemodynamic challenge that cardiopulmonary bypass imposes on the often already-dysfunctional right ventricle. Recently, transcatheter strategies have been developed and have shown promising results. Despite the promising data it has so far not be determined objectively whether interventional treatment of isolated tricuspid regurgitation improves exercise capacity and what role right ventricular function plays in this setting.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Chronic tricuspid regurgitation 2+ to 4+ on a scale of 4+ (moderate to severe) with annular diameter ≥ 40 mm with valve systolic pulmonary pressure (sPAP) ≤ 60 mmHg
New York Heart Association (NYHA) Class II-IV
Symptomatic despite Guideline Directed Medical Therapy (GDMT); at minimum patient on diuretic regimen
Left ventricular ejection fraction ≥ 30%
Symptomatic despite Guideline Directed Medical Therapy (GDMT); at minimum patient on diuretic regimen
The local site Heart Team concur that surgery will not be offered as a treatment option
Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria

Inability to perform cardiopulmonary exercise test
Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation ≥ moderate
Previous tricuspid valve repair or replacement
Severe precapillary pulmonary hypertension (PVR>6 WE)
Cerebrovascular accident (CVA) within the past 6 months
Presence of trans-tricuspid pacemaker or defibrillator leads which cause impingement of the tricuspid valve leaflet as evaluated by echocardiography
Subject is on chronic dialysis and/or anemia (Hb < 9 g/L)
Myocardial infarction or known unstable angina within 30 days prior to the index procedure
Any percutaneous coronary intervention or transcatheter valvular intervention within 30 days prior to the index procedure or planned 3 months post the index procedure
Previous tricuspid valve repair or replacement
Life expectancy of less than 12 months
Patients with cardiac cachexia
Echocardiographic evaluation not available or not suitable for analysis at baseline
Unsuitable anatomy for transcatheter tricuspid intervention
Key information from patients (e.g. NYHA, TR grade) not available
Known allergy or intolerance against the studied device
Persons held in an institution by legal or official order