RESPOND EDGE Post Market Study

NCT04009720 | Terminated FDA Device

• 1 other identifier: S2361
• Study Type: observational
• Target: 200
• Locations: 9 countries
• Sites: 13

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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (2)

• 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)

Interventions

Lotus Edge Device 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (13)

Rigshospitalet

Copenhagen, Denmark

Location

University Helsinki

Helsinki, 00290, Finland

Location

Clinique Pasteur

Toulouse, France

Location

Herzzentrum Universität Leipzig

Leipzig, 50937, Germany

Location

Galway University Hospital

Galway, H91 YR71, Ireland

Location

Az Osp Univ Pisana

Pisa, 56127, Italy

Location

Erasmus MC - Thorax Center

Rotterdam, Netherlands

Location

University of Lund

Lund, SE-221 85, Sweden

Location

Royal Victoria Belfast

Belfast, BT12 6BA, United Kingdom

Location

Royal Sussex County Hospital

Brighton, United Kingdom

Location

The General Infirmary

Leeds, United Kingdom

Location

Oxford John Radcliffe Hospital

Oxford, United Kingdom

Location

New Cross Hospital

Wolverhampton, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Nicolas Dumonteil, MD

  Clinique Pasteur

  PRINCIPAL INVESTIGATOR

• Rajesh K Kharbanda, MD, PhD

  Oxford Heart Centre, John Radcliffe Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: October 11, 2019
• Primary Completion: December 9, 2020
• Study Completion: June 2, 2021
• Last Updated: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); SE (1); DE (1); DK (1); IT (1); FI (1); IE (1); GB (5); NL (1)