RESPOND Post Market Study (RESPOND)
The RESPOND study aimed to collect real-world clinical and device performance outcomes data of the commercially available Lotus Valve used in routine clinical practice for the treatment of severe calcific aortic stenosis. The sample in the RESPOND study comprised over one thousand patients with symptomatic aortic stenosis who were at elevated risk of serious surgical complications, according to local heart team evaluations at 41 centres across Europe, New Zealand, and Latin America. Baseline data collection took place from 2014 to 2016, and participants were followed up for up to 5 years.
Study design
Cohort - clinical, Cohort
Number of participants at first data collection
1,064 (participants)
Age at first data collection
Varied (participants)
Participant year of birth
Varied (participants)
Participant sex
All
Representative sample at baseline?
No
Sample features
Countries
Year of first data collection
2014
Primary Institutions
Erasmus University Medical Centre (Erasmus MC) (Healthcare/Medical, Netherlands)
German Heart Center Berlin (Healthcare/Medical, Germany)
Profile paper DOI
Funders
Boston Scientific (Industry, United States of America)
Ongoing?
No
Data types collected
- Interview – face-to-face
- Interview – phone
- Physical or biological assessment (e.g. blood, saliva, gait, grip strength, anthropometry)
- Secondary data
- None
- None
- Healthcare data
- Mortality data
Engagement
Keywords
