HeartMate III post-market registry
Research type
Research Study
Full title
The HeartMate III Post-Market Registry
IRAS ID
184594
Contact name
Laura Damme
Contact email
Sponsor organisation
Theoretic Europe Ltd
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
Summary of Results
Heart failure is characterised by the inability of the heart to pump enough blood to the vital organs. Some patients with heart failure are eligible for surgically implanted mechanical pumps that assist the heart in supplying blood to vital organs, which prolongs life and improves symptoms.
The HeartMate III is a mechanical pump that is due to gain CE-approval in October, following which it will be implanted at Wythenshawe Hospital as part of the standard management of heart failure patients. This registry will collect anonymised, clinical data on patients receiving a HeartMate III pump for a multi-center post-market registry to monitor safety and effectiveness of the pump in the real-world setting. Anonymised patient data will be submitted to a standardised database managed by Thoratec Corporation, the company that manufactures the HeartMate III pump.
All patients receiving a HeartMate III pump will be eligible. This registry involves only data collection with therefore little risk to patients. Data will be collected during routine hospital visits. Patients will be followed up while they have the pump in place up to a maximum of 2 years . There will be no non-CE approved interventions or deviation from usual care of patients.
Summary of Results
The ELEVATE Registry was conducted in 26 centers in Europe, the Middle East, and Asia between March 2015 and February 2022, with the objective to collect data and evaluate the real-world experience of the HeartMate3 Left Ventricular Assist System (HM3 LVAS) in a post-approval setting. The HM3 LVAS is composed of a centrifugal left ventricular assist device (LVAD) with an outflow graft and modular driveline cable, a pump controller and a power source (i.e. portable Batteries, Power Module, or Mobile Power Unit). This study was designed as a prospective, single arm, post market surveillance and enrolled 540 subjects in 3 different cohorts: 463 received the HM3 LVAD as a primary implant, 19 as a replacement for another durable LVAD (ex. HeartMate II or HVAD) and 58 subjects who had a successful implant procedure but expired prior to having the possibility to sign the Informed Consent form. Anonymized data collected from these 58 subjects was for duration of support and outcome only. The Study was initially designed with a 2 year follow-up, which was extended to 5 years upon completion of the first 24 months of follow-up. The study endpoints (at 2 years and at 5 years only for subjects who consent to participate in the study extension) included: outcomes; quality of life as measured by the EuroQoL-5D-5L; functional status as measured by the Six Minute Walk Test (6MWT) and New York Heart Association (NYHA) Classification; frequency and incidence of pre-defined anticipated adverse event rates; device malfunction; reoperations; and rehospitalizations. The overall survival in the study Full Cohort was 74.5% at 2 Years post-implant and 56.2% at 5 Years post implant. Patient Quality of Life, 6MWT and NYHA class improved significantly at each visit compared to the Baseline. The adverse events reported within the ELEVATE Registry study were as anticipated for the study population and are considered acceptable. As of study completion, there has been no new safety information that changes the safety profile of the HM3 LVAD.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
15/WM/0331
Date of REC Opinion
10 Nov 2015
REC opinion
Further Information Favourable Opinion