Brief Title
RESPOND EDGE Post Market Study
Official Title
Repositionable Lotus Edge™ Valve System - Post Market Evaluation of Real World Clinical Outcomes
Brief 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.
Study Type
Observational [Patient Registry]
Primary Outcome
All-cause mortality (Primary Safety Endpoint)
Condition
Aortic Valve Stenosis
Intervention
Lotus Edge Device
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
200
Start Date
October 11, 2019
Completion Date
June 2, 2021
Primary Completion Date
December 9, 2020
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Nicolas Dumonteil, MD, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT04009720
Organization ID
S2361
Responsible Party
Sponsor
Study Sponsor
Boston Scientific Corporation
Study Sponsor
Nicolas Dumonteil, MD, Principal Investigator, Clinique Pasteur
Verification Date
July 2021