CompletedNot Applicable

Tricuspid Cardiopulmonary Exercise Study

Germany30 participantsStarted 2020-01-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

Influence of transcatheter tricuspid intervention on peak oxygen uptake

Timeframe: 3 month

Influence of transcatheter tricuspid intervention on duration of submaximal exercise tolerance

Timeframe: 3 month

Trial details

NCT IDNCT04559256

SponsorHeart and Diabetes Center North-Rhine Westfalia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-01