NCT04009720

RESPOND EDGE Post Market Study

Repositionable Lotus Edge™ Valve System - Post Market Evaluation of Real World Clinical Outcomes

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Lotus Edge Device	The LOTUS Edge Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] \<1.0 cm2 or AVA index \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.

Timeline

• Start date: 2019-10-11
• Primary completion: 2020-12-09
• Completion: 2021-06-02
• First posted: 2019-07-05
• Last updated: 2021-07-15

Locations

13 sites across 9 countries: Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Sweden, United Kingdom

Regulatory

• FDA-regulated device study