REDUCE LAP-HF RANDOMIZED TRIAL II
Research type
Research Study
Full title
A study to evaluate the Corvia Medical, Inc. IASD® System II, designed to reduce elevated left atrial pressure in Patients with Heart Failure
IRAS ID
226456
Contact name
Wasim Akhtar
Contact email
Sponsor organisation
Corvia Medical, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
9 years, 5 months, 1 days
Research summary
Heart failure (HF) has been described as the “new” or “emerging” epidemic of the 21st century. It is a complex clinical syndrome that can result from any structural or functional cardiac or cardiovascular disorder that impairs the ability of the left ventricle to fill with or eject blood.
Corvia Medical has developed the InterAtrial Shunt Device (IASD) System II designed to reduce left atrial pressure with a standard catheter based approach. The primary component of the system is an implant placed in the atrial septum designed to allow left to right flow between the left and right atria to reduce elevated left atrial pressure.
The primary objective of this study is to evaluate the clinical efficacy and safety of the IASD® System II in symptomatic HF patients. The IASD® System II is indicated for the improvement in quality of life and reduction of HF related symptoms and events in patients with HF with preserved (HFpEF) or mid-range ejection fraction (HFmrEF) with elevated left atrial pressure, whose symptoms remain despite appropriate medical management.
Eligible patients will be randomised to either the treatment or control group. All patients will be sedated, and both treatment and control arm patients will require femoral venous access. Patients will initially be followed for 2 years, at which point they will be unblinded. Patients randomised to the control arm will be allowed to cross-over to the treatment arm following unblinding, provided patient selection criteria are met at that time. All patients will be followed for 5 years following implantation of the IASD® System II. Cross-over patients will be followed for 5 years after cross-over.
Up to 700 subjects will be enrolled into the study in order to obtain a minimum of 380 subjects randomised at up to 60 investigational sites in the USA, and up to 28 investigational sites outside the USA.
REC name
West of Scotland REC 4
REC reference
17/WS/0133
Date of REC Opinion
28 Sep 2017
REC opinion
Further Information Favourable Opinion