Real-world evidence in a national health service: results of the UK CardioMEMS HF System Post-Market Study.

ABSTRACT:

Aims

The CardioMEMS HF System Post-Market Study (COAST) was designed to evaluate the safety, effectiveness, and feasibility of haemodynamic-guided heart failure (HF) management using a small sensor implanted in the pulmonary artery of New York Heart Association (NYHA) Class III HF patients in the UK, Europe, and Australia.

Methods and results

COAST is a prospective, international, multicentre, open-label clinical study (NCT02954341). The primary clinical endpoint compares annualized HF hospitalization rates after 1 year of haemodynamic-guided management vs. the year prior to sensor implantation in patients with NYHA Class III symptoms and a previous HF hospitalization. The primary safety endpoints assess freedom from device/system-related complications and pressure sensor fa

SUBMITTER: Cowie MR 

PROVIDER: S-EPMC8787982 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature