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

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.

Study Overview

• Status: Completed
• Conditions: Transcatheter Aortic Valve Replacement
• Intervention / Treatment: Device: Lotus Valve System

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).

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • Royal Adelaide Hospital
  • Brisbane, Australia
    • Prince Charles Hospital
  • Melbourne, Australia
    • Monash Medical Center
  • Melbourne, Australia
    • St. Vincent's Hospital
• France
  • Lille, France
    • Hôpital Cardiologique CHRU de Lille
  • Lyon, France
    • Hopital Cardiologique de Lyon
  • Paris, France
    • Institut Cardiovasculaire Paris Sud
  • Toulouse, France
    • Centre Hôpital Universitaire Rangueil
  • Toulouse, France
    • Clinique Pasteur
• Germany
  • München, Germany
    • Deutsches Herzzentrum München
  • Siegburg, Germany
    • Helios Klinikum Siegburg
• Italy
  • Catania, Italy
    • Ospedale Ferrarotto
• Netherlands
  • Rotterdam, Netherlands
    • Erasmus MC - Thorax Center
• Spain
  • Madrid, Spain
    • Hospital Clinico San Carlos
• Sweden
  • Lund, Sweden
    • University Hospital of Lund
• Switzerland
  • Bern, Switzerland
    • Inselspital - Universitätsspital Bern
• United Kingdom
  • Belfast, United Kingdom
    • Royal Victoria Hospital
  • Brighton, United Kingdom
    • Royal Sussex County Hospital
  • Leeds, United Kingdom
    • The General Infirmary
  • London, United Kingdom
    • Guys and St. Thomas NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lotus Valve System; Patients enrolled will receive the Lotus Valve.	Device: Lotus Valve System; bioprosthetic bovine pericardial aortic valve; delivery system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective Orifice Area	Effective orifice area measured by echocardiography at 30 days and assessed by an independent core laboratory (ITT population)	30 days
Device Performance Endpoint: Successful Vascular Access	Successful vascular access, delivery and deployment of the Lotus Valve System and successful retrieval of the delivery system as reported from site	Post-procedure
Device Performance Endpoint: Successful Retrieval	Successful retrieval (complete resheathing of the Lotus valve in the catheter and removal from the body) of the Lotus Valve System if retrieval is attempted, as reported from site	Post-procedure
Device Performance Endpoint: Successful Repositioning	Successful repositioning (partial or complete resheathing of the Lotus Valve in the catheter and redeployment in a more accurate position within the aortic valve annulus) of the Lotus Valve System if repositioning is attempted for the last valve attempted, as reported from site	Post-procedure
Device Success According to the Valve Academic Research Consortium (VARC)	Absence of procedural mortality as reported from site AND Correct positioning of a single prosthetic heart valve into the proper anatomical location as reported from site AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation as measured from an independent core lab on the post-procedure echocardiography)	Post-procedure
Grade of Aortic Valve Regurgitation	Grade of paravalvular aortic valve regurgitation at 30 days as measured by echocardiography and assessed by an independent core laboratory	30 days

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Nicolas Dumonteil, MD, Clinique Pasteur

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2012
• Primary Completion (Actual): May 30, 2014
• Study Completion (Actual): May 13, 2019

Study Registration Dates

• First Submitted: June 5, 2012
• First Submitted That Met QC Criteria: June 22, 2012
• First Posted (Estimate): June 26, 2012

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: TP3687 (Other Identifier: Boston Scientific)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No