CardioMEMS Outside US Study
CardioMEMS Heart Failure System "Outside US" Post-Approval Study
St Jude Medical
Duration of Study in the UK
3 years, 0 months, 1 days
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 failure
This study will help confirm if the results of the previous randomised trial in the USA appear generalisable to the UK NHS setting.
London - Dulwich Research Ethics Committee
Date of REC Opinion
27 Feb 2017
Further Information Favourable Opinion