Injectable valve implantation trial (Invite)

Not Applicable

Completed

• Conditions: Topic: Children, Cardiovascular disease; Subtopic: All Diagnoses, Cardiovascular (all Subtopics); Disease: All Diseases, Congenital Heart Disease and Pulmonary Hypertension; Circulatory System; Congenital heart defect

• Registration Number: ISRCTN23538073
• Lead Sponsor: niversity of Bristol

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30944136 protocol (added 10/05/2019) 2023 Results article in https://doi.org/10.1136/bmjopen-2022-065192 (added 02/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-20
• Study Completion: 2020-07-01
• Last Update Posted: 13 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. Patients undergoing either:
1.1. Pulmonary valve replacement (PVR) or
1.2. Pulmonary valve replacement (PVR) with PFO closure that would not require CPB if using an injectable valve or
1.3. Pulmonary valve replacement (PVR) with RVOT reconstruction that does not require CPB if using an injectable valve
2. Patients aged 12-­80 years old inclusive, with an adult valve size (25­31mm)

Exclusion Criteria

1. Prisoners and adults lacking capacity to consent
2. Patients aged 12 to 15 years old under the care of social services
3. Patients with pulmonary valve or artery stenosis requiring patch reconstruction of the pulmonary arteries using CPB
4. Patients having an intra-­cardiac shunt that would require CPB despite using an injectable valve
5. Patients having a RVOT reconstruction that would require CPB despite using an injectable valve
6. Patients requiring other anatomical heart corrections that would require CPB despite using an injectable valve
7. Patients who are unwilling to undergo surgery involving a porcine product
8. Patients unable to provide assent/consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chest drainage in the first 24 post-operative hours.