RESPOND EDGE Post Market Study

Boston Scientific

Status: Terminated

Conditions: Aortic Valve Stenosis

Treatments: Device: Lotus Edge Device

Study type: Observational

Funder types: Industry

Identifiers

NCT04009720

S2361

Details and patient eligibility

About

The purpose of the RESPOND EDGE post market study is to collect real world clinical and device performance outcomes data with the Lotus Edge™ Valve System used in routine clinical practice to demonstrate that the commercially available Lotus Edge Valve System is a safe and effective treatment for patients with severe calcific aortic stenosis.

Full 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 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Subjects will be evaluated for eligibility by the clinical center's heart team per the local standard of practice in accordance with the Directions for Use.