Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement

NCT02202434 | Terminated Results DMC

• 1 other identifier: S2282
• Study Type: interventional
• Target: 1,425
• Locations: 6 countries
• Sites: 58

Brief 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.

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Events Included in the Primary Safety Endpoint

  Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications

  30 days following procedure

• Percentage of Participants With Events Included in the Primary Effectiveness Endpoint

  Composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular aortic regurgitation (based on core lab assessment).

  1 year following procedure

Secondary Outcomes (1)

• Percentage of Participants With Moderate or Greater Paravalvular Aortic Regurgitation

  1 year following procedure

Other Outcomes (28)

• Percentage of Participants With Successful Deployment of the Study Valve

  at discharge or 7 days post-procedure (whichever comes first)

• Percentage of Participants With Successful Retrieval of the Study Valve if Retrieval is Attempted

  at discharge or 7 days post-procedure (whichever comes first)

• Percentage of Participants With Successful Repositioning of the Study Valve if Repositioning is Attempted

  at discharge or 7 days post-procedure (whichever comes first)

Study Arms (6)

Lotus Valve System - Randomized

EXPERIMENTAL

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Device: Lotus Valve System

CoreValve TAVR System - Randomized

ACTIVE COMPARATOR

Transcatheter aortic valve replacement (TAVR) with CoreValve/Evolut R Transcatheter Aortic Valve Replacement System

Device: CoreValve/Evolut R Transcatheter Aortic Valve Replacement System

Lotus Valve Sytem - Single-arm 21mm Cohort

EXPERIMENTAL

Transcatheter aortic valve replacement (TAVR) with 21mm Lotus Valve System

Device: Lotus Valve System

Lotus Valve System - Single-arm Continued Access Cohort

EXPERIMENTAL

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Device: Lotus Valve System

Lotus Valve System - Single-arm Roll-in Cohort

EXPERIMENTAL

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Device: Lotus Valve System

LOTUS Edge Valve System - Single-arm Edge Nested Registry

EXPERIMENTAL

Transcatheter aortic valve replacement (TAVR) with 23mm, 25mm and 27mm LOTUS Edge Valve System.

Device: LOTUS Edge Valve System

Interventions

Lotus Valve System DEVICE

Procedure: Transcatheter aortic valve replacement (TAVR)

Lotus Valve System - Randomized; Lotus Valve System - Single-arm Continued Access Cohort; Lotus Valve System - Single-arm Roll-in Cohort; Lotus Valve Sytem - Single-arm 21mm Cohort

CoreValve/Evolut R Transcatheter Aortic Valve Replacement System DEVICE

Procedure: Transcatheter aortic valve replacement (TAVR)

CoreValve TAVR System - Randomized

LOTUS Edge Valve System DEVICE

Procedure: Transcatheter aortic valve replacement (TAVR)

LOTUS Edge Valve System - Single-arm Edge Nested Registry

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-
• 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).

You may not qualify if:

• Subject has a congenital unicuspid or bicuspid aortic valve.
• Subject has had an acute myocardial infarction (MI) within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total creatine kinase (CK) elevation ≥ twice normal in the presence of creatine kinase-myoglobin band (CK-MB) elevation and/or troponin elevation).
• Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months prior to study enrollment.
• Subject has end-stage renal disease or has glomerular filtration rate (GFR) \<20 (based on Cockcroft-Gault formula).
• Subject has a pre-existing prosthetic aortic or mitral valve.
• Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.
• Subject has a need for emergency surgery for any reason.
• Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis.
• Subject has echocardiographic evidence of new intra-cardiac mass, vegetation or intraventricular or paravalvular thrombus requiring intervention.
• Subject has (hemoglobin) Hgb \<9 g/dL, platelet count \<50,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<1,000 cells/mm3.
• Subject requires chronic anticoagulation therapy after the implant procedure and cannot be treated with warfarin (other anticoagulants are not permitted in the first month) for at least 1 month concomitant with either aspirin or clopidogrel.
• Subject has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen, or will refuse transfusions.
• Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all P2Y12 inhibitors, heparin, nickel, tantalum, titanium, or polyurethanes.
• Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid 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 (58)

Banner Good Samaritan

Phoenix, Arizona, 85018, United States

Location

Scottsdale Healthcare - Shea

Scottsdale, Arizona, 85258, United States

Location

Scripps Clinic

La Jolla, California, 92037, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Veteran's Administration Palo Alto Medical Center

Palo Alto, California, 94304, United States

Location

University of California at Davis Medical Center

Sacramento, California, 95817, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Morton Plant Mease Healthcare System

Clearwater, Florida, 33756, United States

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Baptist Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Emory University Hospital

Atlanta, Georgia, 30308, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Evanston Hospital

Evanston, Illinois, 60201, United States

Location

St. John's Hospital - Prairie Cardiovascular Consultants

Springfield, Illinois, 62701, United States

Location

St. Vincent's Hospital

Indianapolis, Indiana, 46290, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Cardiac & Vascular Rearch Center of Northern Michigan - Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Abbott Northwestern Hospital - Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine - Barnes Jewish Medical Center

St Louis, Missouri, 63110, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07960, United States

Location

Kaleida Health

Buffalo, New York, 14203, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Columbia University Medical Center

New York, New York, 10021, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

NC Heart and Vascular Research - Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Ohio Health Research and Innovation Institute - Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Methodist DeBakey Heart & Vascular Center

Houston, Texas, 77030, United States

Location

Methodist Heart Hospital

San Antonio, Texas, 78229, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

University of Washington Medical Center

Seattle, Washington, 98105, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Providence Health - St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

Location

McGill University Health Centre, Royal Victoria Hospital

Montreal, Quebec, H3A, Canada

Location

Clinique Pasteur

Toulouse, Midi-Pyrenees, 31076, France

Location

Centre Hôpital Universitaire Rangueil

Toulouse, 31059, France

Location

Herzzentrum Universität Leipzig

Leipzig, Saxony, 04289, Germany

Location

Universitares Herzzentrum UKE (Hamburg)

Hamburg, 20246, Germany

Location

Erasmus MC - University Medical Center Rotterdam

Rotterdam, 3015 CE, Netherlands

Location

Related Publications (6)

• Rizik DG, Rajagopal V, Makkar RR, Bajwa T, Kleiman NS, Linke A, Kereiakes DJ, Waksman R, Thourani VH, Stoler RC, Mishkel GJ, Iyer VS, Buchbinder M, Gotberg M, Bjursten H, Allocco DJ, Reardon MJ. Long-term Outcomes of Transcatheter Aortic Valve Replacement With the Lotus Valve vs CoreValve/EvolutR: A Secondary Analysis of the REPRISE III Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2238792. doi: 10.1001/jamanetworkopen.2022.38792.

  PMID: 36301543 DERIVED

• Goel K, O'Leary JM, Barker CM, Levack M, Rajagopal V, Makkar RR, Bajwa T, Kleiman N, Linke A, Kereiakes DJ, Waksman R, Allocco DJ, Rizik DG, Reardon MJ, Lindman BR. Clinical Implications of Physical Function and Resilience in Patients Undergoing Transcatheter Aortic Valve Replacement. J Am Heart Assoc. 2020 Sep;9(17):e017075. doi: 10.1161/JAHA.120.017075. Epub 2020 Aug 28.

  PMID: 32856530 DERIVED

• Meduri CU, Kereiakes DJ, Rajagopal V, Makkar RR, O'Hair D, Linke A, Waksman R, Babliaros V, Stoler RC, Mishkel GJ, Rizik DG, Iyer VS, Schindler J, Allocco DJ, Meredith IT, Feldman TE, Reardon MJ. Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial. J Am Heart Assoc. 2019 Nov 5;8(21):e012594. doi: 10.1161/JAHA.119.012594. Epub 2019 Oct 23.

  PMID: 31640455 DERIVED

• Reardon MJ, Feldman TE, Meduri CU, Makkar RR, O'Hair D, Linke A, Kereiakes DJ, Waksman R, Babliaros V, Stoler RC, Mishkel GJ, Rizik DG, Iyer VS, Gleason TG, Tchetche D, Rovin JD, Lhermusier T, Carrie D, Hodson RW, Allocco DJ, Meredith IT; Reprise III Investigators. Two-Year Outcomes After Transcatheter Aortic Valve Replacement With Mechanical vs Self-expanding Valves: The REPRISE III Randomized Clinical Trial. JAMA Cardiol. 2019 Mar 1;4(3):223-229. doi: 10.1001/jamacardio.2019.0091.

  PMID: 30810703 DERIVED

• Asch FM, Vannan MA, Singh S, Khandheria B, Little SH, Allocco DJ, Meredith IT, Feldman TE, Reardon MJ, Weissman NJ. Hemodynamic and Echocardiographic Comparison of the Lotus and CoreValve Transcatheter Aortic Valves in Patients With High and Extreme Surgical Risk: An Analysis From the REPRISE III Randomized Controlled Trial. Circulation. 2018 Jun 12;137(24):2557-2567. doi: 10.1161/CIRCULATIONAHA.118.034129. Epub 2018 Mar 12.

  PMID: 29530883 DERIVED

• Feldman TE, Reardon MJ, Rajagopal V, Makkar RR, Bajwa TK, Kleiman NS, Linke A, Kereiakes DJ, Waksman R, Thourani VH, Stoler RC, Mishkel GJ, Rizik DG, Iyer VS, Gleason TG, Tchetche D, Rovin JD, Buchbinder M, Meredith IT, Gotberg M, Bjursten H, Meduri C, Salinger MH, Allocco DJ, Dawkins KD. Effect of Mechanically Expanded vs Self-Expanding Transcatheter Aortic Valve Replacement on Mortality and Major Adverse Clinical Events in High-Risk Patients With Aortic Stenosis: The REPRISE III Randomized Clinical Trial. JAMA. 2018 Jan 2;319(1):27-37. doi: 10.1001/jama.2017.19132.

  PMID: 29297076 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Amy Maurer
• Organization: Boston Scientific

amy.maurer@bsci.com

508-683-6647

Study Officials

• David Rizik, MD

  Scottsdale Healthcare - Shea

  PRINCIPAL INVESTIGATOR

• Michael J Reardon, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 29, 2014
• Study Start: September 22, 2014
• Primary Completion: March 8, 2017
• Study Completion: May 21, 2021
• Last Updated: December 17, 2021
• Results First Posted: July 30, 2019

Record last verified: 2021-12

Locations

CA (2); FR (2); NL (1); US (49); AU (2); DE (2)