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REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System | Clinical Trials | Clareo Health

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REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System

REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance

NCT01627691•Boston Scientific Corporation

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

Detailed Description

The REPRISE II clinical study is a prospective, single-arm, multicenter study designed to evaluate the safety and performance of the Lotus Valve System for TAVR in symptomatic subjects who have severe calcific aortic valve stenosis and who are at high risk for surgical aortic valve replacement (SAVR).

Eligibility

Age

70 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject is ≥70 years of age
•Subject has documented calcific native aortic valve stenosis
•Subject has a documented aortic annulus size between ≥19 and ≤27 mm based on pre-procedure diagnostic imaging
•Symptomatic aortic valve stenosis with NYHA Functional Class ≥ II
•Subject is considered high risk for surgical valve replacement
•Heart team assessment that the subject is likely to benefit from valve replacement.
•Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
•Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.

Exclusion Criteria

•Subject has a congenital unicuspid or bicuspid aortic valve.
•Subject with an acute myocardial infarction within 30 days of the index procedure
•Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months, or has any permanent neurologic defect prior to study enrollment.
•Subject is on dialysis or has serum creatinine level \>3.0 mg/dL or 265 µmol/L.
•Subject has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic ring in any position.
•subject cannot have more than moderate mitral, aortic or tricuspid regurgitation
•Subject has a need for emergency surgery for any reason.
•Subject has a history of endocarditis within 12 months of index procedure or evidence of an active systemic infection or sepsis.
•Subject has echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
•Subject has low Hgb, platelet count or \>700,000 cells/mm3, or low white blood cell count.
+14 more criteria

Locations (20)

Royal Adelaide Hospital

Adelaide, Australia

Prince Charles Hospital

Brisbane, Australia

Monash Medical Center

Melbourne, Australia

St. Vincent's Hospital

Melbourne, Australia

Hôpital Cardiologique CHRU de Lille

Lille, France

Hôpital Cardiologique de Lyon

Lyon, France

Institut Cardiovasculaire Paris Sud

Paris, France

Centre Hôpital Universitaire Rangueil

Toulouse, France

Clinique Pasteur

Toulouse, France

Deutsches Herzzentrum München

München, Germany

Key Dates

Start Date

October 8, 2012

Primary Completion Date

May 30, 2014

Completion Date

May 13, 2019

Last Updated

May 12, 2020

Enrollment

250

ACTUAL participants

Conditions

Transcatheter Aortic Valve Replacement

Interventions

Lotus Valve System

DEVICE

Short Versus Long Antiplatelet Therapy After TAVI

NCT06518317

Transcatheter Aortic Valve Replacement

View study

RECRUITING

Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR

NCT04139616

Conduction DisturbancesTranscatheter Aortic Valve Replacement+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 12, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System

Inclusion Criteria

Exclusion Criteria

Short Versus Long Antiplatelet Therapy After TAVI

Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR

Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System

Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement

Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement

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