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

NCT ID: NCT01627691

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-08
• Study Completion Date: 2019-05-13

Brief 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).

Conditions

Transcatheter Aortic Valve Replacement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lotus Valve System

Patients enrolled will receive the Lotus Valve.

Group Type: EXPERIMENTAL

Lotus Valve System

Intervention Type: DEVICE

• bioprosthetic bovine pericardial aortic valve
• delivery system

Interventions

Lotus Valve System

• bioprosthetic bovine pericardial aortic valve
• delivery system

Intervention Type: DEVICE

Eligibility Criteria

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.
• Subject requires chronic anticoagulation therapy and cannot tolerate concomitant therapy with either aspirin or clopidogrel/ticlopidine
• Subject has active peptic ulcer disease or gastrointestinal bleed within the past 3 months, other bleeding diathesis or coagulopathy or will refuse transfusions.
• Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all thienopyridines, heparin, nickel, tantalum, titanium, or polyurethanes.
• Subject has a life expectancy of less than 12 months due to non-cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrollment.
• Subject has hypertrophic obstructive cardiomyopathy.
• Subject has any therapeutic invasive cardiac procedure within 30 days prior to the index procedure (except for pacemaker implantation which is allowed).
• Subject has untreated coronary artery disease.
• Subject has documented left ventricular ejection fraction <30%.
• Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
• Subject has severe peripheral vascular disease or symptomatic carotid or vertebral disease.
• Narrow Femoral artery lumen precludes the use of either Lotus device size, or severe iliofemoral tortuosity or calcification that would prevent safe placement of the introducer sheath.
• Current problems with substance abuse (e.g., alcohol, etc.).
• Subject is participating in another investigational drug or device study that has not reached its primary endpoint.
• Patient has preexisting untreated conduction system disorder that requires new pacemaker implantation.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Dumonteil, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Pasteur

Locations

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

Helios Klinikum Siegburg

Siegburg, , Germany

Ospedale Ferrarotto

Catania, , Italy

Erasmus MC - Thorax Center

Rotterdam, , Netherlands

Hospital Clinico San Carlos

Madrid, , Spain

University Hospital of Lund

Lund, , Sweden

INSELSPITAL - Universitätsspital Bern

Bern, , Switzerland

Royal Victoria Hospital

Belfast, , United Kingdom

Royal Sussex County Hospital

Brighton, , United Kingdom

The General Infirmary

Leeds, , United Kingdom

Guys and St. Thomas NHS Foundation Trust

London, , United Kingdom

Countries

Australia; France; Germany; Italy; Netherlands; Spain; Sweden; Switzerland; United Kingdom

References

Meredith IT, Walters DL, Dumonteil N, Worthley SG, Tchetche D, Manoharan G, Blackman DJ, Rioufol G, Hildick-Smith D, Whitbourn RJ, Lefevre T, Lange R, Muller R, Redwood S, Feldman TE, Allocco DJ, Dawkins KD. 1-Year Outcomes With the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients With Severe Aortic Stenosis: Results of the REPRISE II Study. JACC Cardiovasc Interv. 2016 Feb 22;9(4):376-384. doi: 10.1016/j.jcin.2015.10.024.

Reference Type: DERIVED

PMID: 26892084 (View on PubMed)

Meredith Am IT, Walters DL, Dumonteil N, Worthley SG, Tchetche D, Manoharan G, Blackman DJ, Rioufol G, Hildick-Smith D, Whitbourn RJ, Lefevre T, Lange R, Muller R, Redwood S, Allocco DJ, Dawkins KD. Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study. J Am Coll Cardiol. 2014 Sep 30;64(13):1339-48. doi: 10.1016/j.jacc.2014.05.067.

Reference Type: DERIVED

PMID: 25257635 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TP3687

Identifier Type: OTHER

Identifier Source: secondary_id

TP3687

Identifier Type: -

Identifier Source: org_study_id