TARGET STUDY, Version 5.0, dated 21 February 2024
Research type
Research Study
Full title
Safety and Performance of the Cardiovalve TR Replacement System for Tricuspid Regurgitation
IRAS ID
330948
Contact name
David Hildick-Smith
Contact email
Sponsor organisation
Cardiovalve Ltd.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
not applicable, not applicable
Duration of Study in the UK
5 years, 3 months, 31 days
Research summary
The tricuspid heart valve (TV) controls the blood flow from the right atrium to the right ventricle of the heart. A tricuspid valve that does not close properly leads to leakage (partial backflow of blood in the wrong direction with each contraction of the right ventricle), also known as Tricuspid Regurgitation (TR). This is a common heart valve disease that is reported to affect more than 70 million people worldwide. It increases the workload on the heart and, if left untreated, it can increase the risk of a worsening heart disease. One-year mortality increases with increasing severity of TR. Yet, most patients with severe TR are treated with medication if there is no other indication for cardiac surgery, and isolated TV surgery remains rare. To address this unmet clinical need, various minimally invasive TV therapies are being developed as an alternative to surgery in extreme- and high-risk patients with severe functional TR.
The Cardiovalve TR valve replacement system is designed to treat patients with severe TR that would otherwise require surgery. The implant is inserted into the diseased TV via the groin in a minimally invasive procedure under fluoroscopic and echocardiographic guidance.TARGET will recruit 150 patients in around 50 hospitals experienced in minimally invasive heart valve treatments in the UK, European Union, and Canada.
After treatment with the Cardiovalve implant patients remain in the study for 5 years with follow-up at hospital discharge (or 7 days post-procedure, whichever comes first), followed by hospital visits at 30 days, 6 months, 12 months and then yearly until 5 years. These visits include a physical examination, ECG, blood tests, determination of clinical assessment scores and transthoracic echocardiography (TTE). Patients are also asked to perform a six-minute walk test, complete a quality-of-life questionnaire, and undergo ankle circumference measurements.
REC name
London - Stanmore Research Ethics Committee
REC reference
24/LO/0088
Date of REC Opinion
2 May 2024
REC opinion
Further Information Favourable Opinion