RESPOND EDGE Post Market Study

Aortic Valve Stenosis Clinical Trial

— RESPOND EDGE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04009720
• Other study ID #: S2361
• Status: Terminated
• Start date: October 11, 2019
• Est. completion date: June 2, 2021

Study information

• Verified date: July 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: June 2, 2021
• Est. primary completion date: December 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Finland	University Helsinki	Helsinki
France	Clinique Pasteur	Toulouse
Germany	Herzzentrum Universität Leipzig	Leipzig
Ireland	Galway University Hospital	Galway
Italy	Az Osp Univ Pisana	Pisa
Netherlands	Erasmus MC - Thorax Center	Rotterdam
Sweden	University of Lund	Lund
United Kingdom	Royal Victoria Belfast	Belfast
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	The General Infirmary	Leeds
United Kingdom	Oxford John Radcliffe Hospital	Oxford
United Kingdom	New Cross Hospital	Wolverhampton

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Denmark,  Finland,  France,  Germany,  Ireland,  Italy,  Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)