NCT02854319 (REPRISE EDGE) is a NA clinical trial of LOTUS Edge Valve System in Aortic Valve Stenosis, sponsored by Boston Scientific Corporation.

Who is sponsoring NCT02854319?

NCT02854319 is sponsored by Boston Scientific Corporation.

What drugs are being tested in NCT02854319?

Interventions in NCT02854319: LOTUS Edge Valve System.

What condition does NCT02854319 study?

NCT02854319 studies Aortic Valve Stenosis.

Is NCT02854319 still recruiting?

NCT02854319 is currently terminated. Last updated 31 May 2018.

Last reviewed 2018-05-31 · How we verify

NCT02854319: REPRISE EDGE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System

Terminated NA Last updated 31 May 2018

What this trial tests

NA trial testing LOTUS Edge Valve System in Aortic Valve Stenosis in 15 participants. Terminated before completion.

Timeline

7 September 2016

Primary endpoint
25 October 2016

13 March 2018

Quick facts

Lead sponsor	Boston Scientific Corporation
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	7 September 2016
Primary completion	25 October 2016
Estimated completion	13 March 2018
Sites	3 locations across Denmark, France, Sweden

Drugs / interventions tested

LOTUS Edge Valve System

Conditions studied

Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →

Sponsor

Boston Scientific Corporation — full company profile →

Who can join

70 and older, any sex, with Aortic Valve Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of the REPRISE EDGE study is to confirm the acute performance and safety of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set for transcatheter aortic valve implantation (TAVI) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of LOTUS Edge Valve System

Trials testing the same drug.

NCT03618095 — REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects · NA · terminated
NCT02202434 — Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement · NA · terminated

Other recruiting trials for Aortic Valve Stenosis

Currently open trials in the same condition.

NCT07455292 — Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging · NA · recruiting
NCT07008911 — CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation · NA · recruiting
NCT07145463 — Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the VitaFlow Liberty® Flex Transcatheter Aorti · NA · recruiting
NCT07520656 — Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing · recruiting
NCT07267117 — Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease · recruiting

Other Boston Scientific Corporation trials

Trials by the same sponsor.

NCT07458243 — Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT · not yet recruiting
NCT07458217 — Combined CM and STN Stimulation for Motor Epilepsy · NA · not yet recruiting
NCT07276815 — OverStitch NXT Endoscopic Suture System · NA · not yet recruiting
NCT07353710 — A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure · NA · not yet recruiting
NCT07195708 — Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365') · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02854319 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boston Scientific Corporation
Last refreshed: 31 May 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02854319.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing