Clinical trial NCT04009720: RESPOND EDGE Post Market Study
Official title: Repositionable Lotus Edge™ Valve System - Post Market Evaluation of Real World Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Aortic Valve Stenosis
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: All-cause mortality (Primary Safety Endpoint)
timeFrame: 30 days
measure: Mean aortic valve pressure gradient (Primary Effectiveness Endpoint)
timeFrame: Within 7 days after the index procedure (Pre-discharge)
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Helsinki
country: Finland
facility: University Helsinki
city: Toulouse
country: France
facility: Clinique Pasteur
city: Leipzig
country: Germany
facility: Herzzentrum Universität Leipzig
city: Galway
country: Ireland
facility: Galway University Hospital
city: Pisa
country: Italy
facility: Az Osp Univ Pisana
city: Rotterdam
country: Netherlands
facility: Erasmus MC - Thorax Center
city: Lund
country: Sweden
facility: University of Lund
city: Belfast
country: United Kingdom
facility: Royal Victoria Belfast
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Leeds
country: United Kingdom
facility: The General Infirmary
city: Oxford
country: United Kingdom
facility: Oxford John Radcliffe Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Clinique Pasteur
name: Nicolas Dumonteil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oxford Heart Centre, John Radcliffe Hospital
name: Rajesh K Kharbanda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: