Tricuspid regurgitation, heart failure Circulatory System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with severe or greater tricuspid regurgitation and deemed suitable for Transcatheter tricuspid valve intervention after multidisciplinary team discussion.
Exclusion criteria
Exclusion criteria: 1. Anatomical or haemodynamic exclusion for TTVI 2. Pregnancy 3. Age moderate in severity) non-tricuspid valvular disease 6. Another indication for cardiac surgery 7. Enrolment in other studies that may lead to deviation from either protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cardiac output measured invasively immediately before and after tricuspid intervention procedure. 2. Cardiac output measured non-invasively at baseline, the day of and <48hrs after tricuspid intervention procedure, at 12 weeks follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in cardiac contractility measured invasively: measured immediately before and after tricuspid intervention procedure. 2. Change in cardiac function (ejection fraction and cardiac output) measured with non-invasive cardiac imaging: measured at baseline, the day of and <48hrs after tricuspid intervention procedure, at 12 weeks follow-up 3. Change in symptoms measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ): measured at baseline and at 12 weeks follow-up 4. Change in exercise capacity measured with 6-minute walk test (6MWT) and average daily step count measured with wearable activity monitors: measured at baseline and at 12 weeks follow-up | — |
Countries
England, United Kingdom