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

NCT01627691 | Completed Results DMC

• 1 other identifier: TP3687
• Study Type: interventional
• Target: 250
• Locations: 9 countries
• Sites: 20

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.

Conditions

Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (2)

• Primary Device Performance Endpoint: Mean Aortic Valve Pressure Gradient at 30 Days Post Implant Procedure

  Mean aortic valve pressure gradient at 30 days post implant procedure as measured by echocardiography and assessed by an independent core laboratory.

  30 days

• Primary Safety Endpoint: All-cause Mortality at 30 Days Post Implant Procedure

  Mortality at 30 days from all patients enrolled in the study (ITT population): the proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure

  30 days

Secondary Outcomes (6)

• Effective Orifice Area

  30 days

• Device Performance Endpoint: Successful Vascular Access

  Post-procedure

• Device Performance Endpoint: Successful Retrieval

  Post-procedure

• Device Performance Endpoint: Successful Repositioning

  Post-procedure

• Device Success According to the Valve Academic Research Consortium (VARC)

  Post-procedure

Study Arms (1)

Lotus Valve System

EXPERIMENTAL

Patients enrolled will receive the Lotus Valve.

Device: Lotus Valve System

Interventions

Lotus Valve System DEVICE

* bioprosthetic bovine pericardial aortic valve * delivery system

Lotus Valve System

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (20)

Royal Adelaide Hospital

Adelaide, Australia

Location

Prince Charles Hospital

Brisbane, Australia

Location

Monash Medical Center

Melbourne, Australia

Location

St. Vincent's Hospital

Melbourne, Australia

Location

Hôpital Cardiologique CHRU de Lille

Lille, France

Location

Hôpital Cardiologique de Lyon

Lyon, France

Location

Institut Cardiovasculaire Paris Sud

Paris, France

Location

Centre Hôpital Universitaire Rangueil

Toulouse, France

Location

Clinique Pasteur

Toulouse, France

Location

Deutsches Herzzentrum München

München, Germany

Location

Helios Klinikum Siegburg

Siegburg, Germany

Location

Ospedale Ferrarotto

Catania, Italy

Location

Erasmus MC - Thorax Center

Rotterdam, Netherlands

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

University Hospital of Lund

Lund, Sweden

Location

INSELSPITAL - Universitätsspital Bern

Bern, Switzerland

Location

Royal Victoria Hospital

Belfast, United Kingdom

Location

Royal Sussex County Hospital

Brighton, United Kingdom

Location

The General Infirmary

Leeds, United Kingdom

Location

Guys and St. Thomas NHS Foundation Trust

London, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 26892084 DERIVED

• 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.

  PMID: 25257635 DERIVED

Results Point of Contact

• Title: Anne Cornaille
• Organization: Boston Scientific

anne.cornaille@bsci.com

+33608863659

Study Officials

• Nicolas Dumonteil, MD

  Clinique Pasteur

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 26, 2012
• Study Start: October 8, 2012
• Primary Completion: May 30, 2014
• Study Completion: May 13, 2019
• Last Updated: May 12, 2020
• Results First Posted: September 10, 2019

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); SE (1); CH (1); FR (5); IT (1); NL (1); ES (1); AU (4); GB (4)