RESPOND EDGE Post Market Study
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Aortic Valve Stenosis
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The RESPOND EDGE study is a prospective, open label, single arm, multi-center, observational post market study designed to collect real world clinical and device performance outcomes data of the commercially available Lotus Edge Valve used in routine clinical practice for the treatment of severe cal...
The RESPOND EDGE study is a prospective, open label, single arm, multi-center, observational post market study designed to collect real world clinical and device performance outcomes data of the commercially available Lotus Edge Valve used in routine clinical practice for the treatment of severe calcific aortic stenosis. Approximately 200 real-world, consecutive subjects will be enrolled at up to 20 study centers. The study duration for each subject is expected to be approximately 2 years. Implanted subjects will be contacted for follow-up at 30 days, 1 and 2 years post index procedure. Subjects who are enrolled but not implanted with a Lotus Edge valve will be followed for safety through 30 days after the initial attempted index procedure. Collection of safety events will include any serious adverse event (SAE), serious adverse device effect (SADE), adverse device effect (ADE), unanticipated serious adverse device effect (USADE), and all Valve Academic Research Consortium (VARC) events regardless of seriousness and device relationship through 2 year follow-up.
Tracking Information
- NCT #
- NCT04009720
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nicolas Dumonteil, MD Clinique Pasteur Principal Investigator: Rajesh K Kharbanda, MD, PhD Oxford Heart Centre, John Radcliffe Hospital
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