CIP-2101-01
Research type
Research Study
Full title
Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
IRAS ID
234748
Contact name
Julien Delumeau
Contact email
Sponsor organisation
4Tech Cardio, Ltd
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
ACTRN12617000829314, Australian New Zealand Clinical Trials Registry
Duration of Study in the UK
3 years, 1 months, 31 days
Research summary
The study is a multi-center, prospective, non-randomized study designed to assess the 30-Day All-Cause Mortality of the TriCinch Coil System. \n\nIn this study, up to 90 subjects will be attempted for an implantation with the TriCinch Coil system at up to 20 sites. We estimate approximately 250 patients will be consented to achieve up to 90 patients attempted for device implantation: \n\n- Up to 20 subjects will be attempted for implantation and included in a roll-in phase (up to 1 roll-in subject per center) before commencing enrollment in the primary endpoint cohort. \n\n- 70 subjects will be attempted for implantation with the investigational device to support the primary endpoint evaluation.\n\nSubjects who are successfully implanted with the study device are followed-up in accordance with the follow-up schedule. Subjects in which the delivery system was introduced but who were not successfully implanted will be followed 30 days post procedure to ensure there are no adverse events associated with the attempted procedure. \n\nSuccessfully implanted subjects will be asked to undergo at specific intervals: \n- Trans-Oesophageal Echo (TOE) \t\n- Trans-Thoracic Echo (TTE)\n- ECG \n- Blood Tests\n- NYHA Class\n- Quality of Life (QoL) Questionnaire:Kansas City Cardiomyopathy Questionnaire (KCCQ) and Six-Minute Walk Test (6MWT).\n\nSubjects will be followed at months 1,3,6, 12 and 24 months for a total study duration of 2 years. \n
REC name
South West - Frenchay Research Ethics Committee
REC reference
17/SW/0255
Date of REC Opinion
16 Feb 2018
REC opinion
Further Information Favourable Opinion