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Predicting outcomes following intervention for tricuspid regurgitation

Predicting functional and clinical outcomes following transcatheter tricuspid valve intervention for severe tricuspid regurgitation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN28956316
Enrollment
72
Registered
2025-04-03
Start date
2025-03-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tricuspid regurgitation, heart failure Circulatory System

Interventions

We will observe patients undergoing Transcatheter Tricuspid valve interventions for severe tricuspid regurgitation. We will perform some additional functional and quality-of-life assessment at baselin

Sponsors

King's College London
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 110 Years

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

MeasureTime 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

MeasureTime 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

Contacts

Public ContactBenedict McDonaugh
benedict.mcdonaugh@gstt.nhs.uk+44 20 7188 7188

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026