RESPOND EDGE Post Market Study

Terminated

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT04009720
• Lead Sponsor: Boston Scientific Corporation

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 Timeline

• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-05
• Study Start: 2019-10-11
• Primary Completion: 2020-12-09
• Study Completion: 2021-06-02
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-11
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean aortic valve pressure gradient (Primary Effectiveness Endpoint)	Within 7 days after the index procedure (Pre-discharge)	The primary effectiveness endpoint is the mean aortic valve pressure gradient (mmHg) at pre-discharge as determined by an independent core laboratory. The primary analysis set for the primary effectiveness endpoint is the implanted analysis set.
All-cause mortality (Primary Safety Endpoint)	30 days	The primary safety endpoint is all-cause mortality at 30 days after the implant procedure. The primary safety endpoint will be evaluated on an intention to- treat (ITT) basis (all subjects enrolled, whether or not a Lotus Edge Valve is implanted).

Trial Locations

Locations (13)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

University Helsinki; 🇫🇮 Helsinki, Finland

Clinique Pasteur; 🇫🇷 Toulouse, France

Herzzentrum Universität Leipzig; 🇩🇪 Leipzig, Germany

Galway University Hospital; 🇮🇪 Galway, Ireland

Az Osp Univ Pisana; 🇮🇹 Pisa, Italy

Erasmus MC - Thorax Center; 🇳🇱 Rotterdam, Netherlands

University of Lund; 🇸🇪 Lund, Sweden

Royal Victoria Belfast; 🇬🇧 Belfast, United Kingdom

Royal Sussex County Hospital; 🇬🇧 Brighton, United Kingdom

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