REPRISE III: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Randomized Clinical Evaluation

Status: Terminated
Location: See all (58) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: No
View:

• Subject has documented calcific, severe native aortic stenosis with an initial aortic valve area (AVA) of ≤1.0 cm2 (or AVA index of ≤0.6 cm2/m2) and a mean pressure gradient >40 mm Hg or jet velocity >4.0 m/s, as measured by echocardiography and/or invasive hemodynamics

• Subject has a documented aortic annulus size of ≥18 mm and ≤29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) and, for the randomized cohort, is deemed treatable with an available size of both test and control device. For the U.S. Continued Access Study cohort the acceptable aortic annulus size is ≥20 mm and ≤27 mm.

• Subject has symptomatic aortic valve stenosis with New York Heart Association (NYHA) Functional Class ≥ II

• There is agreement by the heart team (which must include a site investigator interventionalist and a site investigator cardiac surgeon) that subject is at high or extreme operative risk for surgical valve replacement (see note below for definitions of extreme and high risk, the required level of surgical assessment, and CRC confirmation) and that TAVR is appropriate. Additionally, subject has at least one of the following.

• Society of Thoracic Surgeons (STS) score ≥8% -OR-

• If STS <8, subject has at least one of the following conditions: Hostile chest, porcelain aorta, severe pulmonary hypertension (>60 mmHg), prior chest radiation therapy, coronary artery bypass graft(s) at risk with re-operation, severe lung disease (need for supplemental oxygen, forced expiratory volume in 1 second [FEV1] <50% of predicted, diffusing capacity of the lungs for carbon monoxide [DLCO] <60%, or other evidence of severe pulmonary dysfunction), neuromuscular disease that creates risk for mechanical ventilation or rehabilitation after surgical aortic valve replacement, orthopedic disease that creates risk for rehabilitation after surgical aortic valve replacement, Childs Class A or B liver disease (subjects with Childs Class C disease are not eligible for inclusion in this trial), frailty as indicated by at least one of the following: 5-meter walk >6 seconds, Katz Assessment of Daily Living (Katz ADL) score of 3/6 or less, body mass index <21, wheelchair bound, unable to live independently, age ≥90 years, other evidence that subject is at high or extreme risk for surgical valve replacement (CRC must confirm agreement with site heart team that subject meets high or extreme risk definition)

• Heart team (which must include a cardiac interventionalist and an experienced cardiac surgeon) 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.

• Note: Extreme operative risk and high operative risk are defined as follows: Extreme Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk ≥50% at 30 days; High Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk ≥15% at 30 days. Risk of operative mortality and morbidity must be assessed via an in-person evaluation by a center cardiac surgeon and must be confirmed by the CRC (which must include an experienced cardiac surgeon).

Locations
United States
Arizona
Banner Good Samaritan
Phoenix
Scottsdale Healthcare - Shea
Scottsdale
California
Scripps Clinic
La Jolla
Cedars-Sinai Medical Center
Los Angeles
Veteran's Administration Palo Alto Medical Center
Palo Alto
University of California at Davis Medical Center
Sacramento
Stanford University Medical Center
Stanford
Washington, D.c.
Washington Hospital Center
Washington
Florida
Morton Plant Mease Healthcare System
Clearwater
Delray Medical Center
Delray Beach
Baptist Cardiac and Vascular Institute
Miami
University of Miami Hospital
Miami
Georgia
Emory University Hospital
Atlanta
Piedmont Hospital
Atlanta
Illinois
Evanston Hospital
Evanston
St. John's Hospital - Prairie Cardiovascular Consultants
Springfield
Indiana
St. Vincent's Hospital
Indianapolis
Kansas
University of Kansas Hospital
Kansas City
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Maryland
Union Memorial Hospital
Baltimore
Michigan
University of Michigan
Ann Arbor
Cardiac & Vascular Rearch Center of Northern Michigan - Northern Michigan Hospital
Petoskey
William Beaumont Hospital
Royal Oak
Minnesota
Abbott Northwestern Hospital - Minneapolis Heart Institute
Minneapolis
University of Minnesota Medical Center
Minneapolis
Mayo Clinic
Rochester
Missouri
Washington University School of Medicine - Barnes Jewish Medical Center
Saint Louis
North Carolina
Duke University Medical Center
Durham
NC Heart and Vascular Research - Rex Hospital
Raleigh
Wake Forest University School of Medicine
Winston-salem
New Jersey
Morristown Memorial Hospital
Morristown
New York
Kaleida Health
Buffalo
North Shore University Hospital
Manhasset
Columbia University Medical Center
New York
Ohio
Lindner Center for Research and Education at The Christ Hospital
Cincinnati
Cleveland Clinic Foundation
Cleveland
Ohio Health Research and Innovation Institute - Riverside Methodist Hospital
Columbus
Ohio State University Medical Center
Columbus
Oregon
Providence St. Vincent Medical Center
Portland
Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia
University of Pittsburgh Medical Center
Pittsburgh
Texas
Baylor Heart and Vascular Hospital
Dallas
Medical City Dallas Hospital
Dallas
Methodist DeBakey Heart & Vascular Center
Houston
Methodist Heart Hospital
San Antonio
Virginia
Inova Fairfax Hospital
Falls Church
Washington
Swedish Medical Center
Seattle
University of Washington Medical Center
Seattle
Wisconsin
Aurora St. Luke's Medical Center
Milwaukee
Other Locations
Australia
The Prince Charles Hospital
Chermside
Monash Medical Centre
Clayton
Canada
McGill University Health Centre, Royal Victoria Hospital
Montreal
Providence Health - St. Paul's Hospital
Vancouver
France
Centre Hôpital Universitaire Rangueil
Toulouse
Clinique Pasteur
Toulouse
Germany
Universitares Herzzentrum UKE (Hamburg)
Hamburg
Herzzentrum Universität Leipzig
Leipzig
Netherlands
Erasmus MC - University Medical Center Rotterdam
Rotterdam
Time Frame
Start Date: September 22, 2014
Completion Date: May 21, 2021
Participants
Target number of participants: 1425
Treatments
Experimental: Lotus Valve System - Randomized
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Active Comparator: CoreValve TAVR System - Randomized
Transcatheter aortic valve replacement (TAVR) with CoreValve/Evolut R Transcatheter Aortic Valve Replacement System
Experimental: Lotus Valve Sytem - Single-arm 21mm Cohort
Transcatheter aortic valve replacement (TAVR) with 21mm Lotus Valve System
Experimental: Lotus Valve System - Single-arm Continued Access Cohort
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Experimental: Lotus Valve System - Single-arm Roll-in Cohort
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Experimental: LOTUS Edge Valve System - Single-arm Edge Nested Registry
Transcatheter aortic valve replacement (TAVR) with 23mm, 25mm and 27mm LOTUS Edge Valve System.
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov