CardioMEMS Outside US Study
Research type
Research Study
Full title
CardioMEMS Heart Failure System "Outside US" Post-Approval Study
IRAS ID
219676
Contact name
Susan Neville
Contact email
Sponsor organisation
St Jude Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Research Summary
Patients being treated for heart failure may need to be admitted to hospital for treatment of symptoms. It is known that the blood pressure in the lung arteries increases a few days before symptoms cause hospitalisation. In this study a pressure sensor (CardioMEMS) is implanted in the lung artery. It measures pressure and transmits the data on a daily basis to the hospital. The hospital staff can monitor the pressure and if it starts to rise they can modify the patients treatment before the pressure gets too high and causes hospitalisation. In addition, they can modify treatment to maintain the pressure in the lung arteries at a 'target' range that has been shown in a previous randomised trial in the USA to reduce the risk of the need for hospitalisation for symptom control (The Champion Study).
Study visits are for screening, sensor implant, 1 month, 6 months, 12 months, 18 months and 24 months.
About 150 patients will be recruited at 10 centres in the UK.
The primary effectiveness endpoint will compare the annualized HF hospitalization rate at 1 year in the study to the HF hospitalization rate in the year prior to enrolment.
Primary safety endpoints will be evaluated at 2 years:
1) Freedom from device/system related complications
2) Freedom from pressure sensor failureThis study will help confirm if the results of the previous randomised trial in the USA appear generalisable to the UK NHS setting.
Summary of results
An evaluation (CardioMEMS Hf System OUS Post Market Study) has been conducted on the CardioMEMS™ HF System. The objective of the study was to confirm the safety and effectiveness of the CardioMEMS™ HF System in subjects with New York Heart Association (NYHA) Class III heart failure (HF) who experienced a heart failure hospitalization (HFH) in the previous year.
The CardioMEMS™ HF System consists of an implantable wireless sensor with delivery catheter, patient or hospital electronics system, and a patient database (Integrated Merlin.net website for patient data management).
The CardioMEMS HF System originally received FDA approval in May 2014. This clinical study was a prospective, non-randomized, open-label, multi-center, post-market study designed to provide safety and effectiveness data regarding the use of the CardioMEMSTM HF System in a commercial setting. A total of 321 patients at 38 sites were consented, of which 304 underwent a CardioMEMS sensor implant. Implantation was successful in 299 cases between July 26, 2016 and the last subject on December 16, 2021.
All implanted patients were considered enrolled in the study and followed for 24 months or until they exited the study. The last follow-up visit was conducted on December 8, 2023.
The primary safety endpoints were (1) freedom from device/system-related complications (DSRCs) at 2 years and (2) freedom from pressure sensor failure at 2 years. The primary effectiveness endpoint was the annualized HFH rate at 1 year compared to the annualized HFH rate for 1 year prior to implant.
The primary safety endpoint of freedom from DSRCs at 2 years was 100%, exceeding the pre-specified objective performance criterion of 80%. Similarly, the primary safety endpoint of freedom from sensor failure at 2 years was 99.7%, also exceeding the pre-specified objective performance criterion of 90%.
After sensor implant, the rate of HFHs was reduced by 69% in the year post sensor implant when compared to the prior year (p<0.001). This result was similar in males and females (HR: 0.32 vs. 0.28, p=0.4621), in patients with or without preserved ejection fraction (HR: 0.25 vs 0.35, p=0.1144), and independent of the ischemic etiology of HF (HR: 0.28 vs 0.33, p=0.4276) or by the presence or not of an ICD/CRT-D device (HR: 0.26 vs 0.36, p=0.1077). Since all of the primary safety and the primary effectiveness endpoints were met, the study is considered a success.
Significant improvements were also found in the EQ-5D-5L and Visual Analog Score (VAS) (68.0 ± 19.3 vs 60.0 ± 21.6; p<0.001). Although the same result was not always found in all the questionnaire components (Mobility, Self-Care, Usual Activities, Pain/Discomfort Scores), patients were less prone to Anxiety or depression at 2 years (Anxiety/Depression Score, p=0.0293 vs baseline).
In summary, this study demonstrated the safety and effectiveness of the CardioMEMS HF System to treat NYHA Class III patients with a prior heart failure hospitalization.
REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/0041
Date of REC Opinion
27 Feb 2017
REC opinion
Further Information Favourable Opinion