RESPOND EDGE Post Market Study (RESPOND EDGE)

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

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.

Study Overview

• Status: Terminated
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Lotus Edge Device

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
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
• Finland
  • Helsinki, Finland, 00290
    • University Helsinki
• France
  • Toulouse, France
    • Clinique Pasteur
• Germany
  • Leipzig, Germany, 50937
    • Herzzentrum Universität Leipzig
• Ireland
  • Galway, Ireland, H91 YR71
    • Galway University Hospital
• Italy
  • Pisa, Italy, 56127
    • Az Osp Univ Pisana
• Netherlands
  • Rotterdam, Netherlands
    • Erasmus MC - Thorax Center
• Sweden
  • Lund, Sweden, SE-221 85
    • University of Lund
• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Royal Victoria Belfast
  • Brighton, United Kingdom
    • Royal Sussex County Hospital
  • Leeds, United Kingdom
    • The General Infirmary
  • Oxford, United Kingdom
    • Oxford John Radcliffe Hospital
  • Wolverhampton, United Kingdom
    • New Cross Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form and are selected to receive a LOTUS Edge valve will be evaluated for enrollment in this study.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality (Primary Safety Endpoint)	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).	30 days
Mean aortic valve pressure gradient (Primary Effectiveness Endpoint)	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.	Within 7 days after the index procedure (Pre-discharge)

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Nicolas Dumonteil, MD, Clinique Pasteur; Principal Investigator: Rajesh K Kharbanda, MD, PhD, Oxford Heart Centre, John Radcliffe Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2019
• Primary Completion (Actual): December 9, 2020
• Study Completion (Actual): June 2, 2021

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 11, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: S2361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No