CoreValve™ Evolut R™ FORWARD Study

NCT ID: NCT02592369

Last Updated: 2020-04-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1060 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2020-02-06

Brief Summary

Prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

Detailed Description

The study objective is to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

Prospective, single arm, multi-center, observational, post market study. In Australia and Canada it is a prospective, single arm, multi-center pre-market study.

Up to 60 centers worldwide. Geographies may include Europe, Australia, Middle East and Africa, Latin America and Canada.

Approximately 1000 implanted subjects, consented for follow-up through three years.

For each subject, data will be collected preoperatively, intra-operatively, at hospital discharge, 30 days, 1, 2 and 3 years.

Conditions

Aortic Valve Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Medtronic CoreValve™ Evolut R™ System

The Evolut R System is intended for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, to be at high or extreme risk for open heart surgery. The Evolut R TAV treats aortic stenosis by displacing and functionally replacing the dysfunctional native valve with a bioprosthetic valve delivered on a catheter while the heart is still beating, thus avoiding the risks of cardiopulmonary bypass. Its intended performance is to relieve aortic valve stenosis without inducing significant regurgitation, thereby restoring effective aortic valve function.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement
• Acceptable candidate for elective treatment with the Evolut R System and in conformity with the local regulatory and medico economic context
• Age ≥80 years OR considered to be at high or greater risk for surgical aortic valve replacement (AVR) where high risk is defined as:

• Society of Thoracic Surgeons (STS) predicted risk of mortality ≥8% OR
• Documented heart team agreement of risk for AVR due to frailty or comorbidities.
• Geographically stable and willing to return to the implanting site for all follow-up visits
• Of legal age to provide informed consent (patient Informed Consent or Data Release Form) in the country where they enroll in the trial
• The patient has been informed of the nature of the study, is able and willing to provide consent without assistance from a legal representative and has consented to participate, and has authorized the collection and release of his/her medical information by signing a Patient Informed Consent or Data Release Form.

Exclusion Criteria

• Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated
• Preexisting mechanical heart valve in aortic position
• Ongoing sepsis, including active endocarditis
• Anatomically not suitable for the Evolut R system
• Estimated life expectancy of less than 1 year
• Participating in another trial that may influence the outcome of this trial
• Need for emergency surgery for any reason

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eberhard Grube, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bonn

Stephan Windecker, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

INSELSPITAL, Universitätsspital Bern

Locations

Flinders Medical Centre

Adelaide, , Australia

Monash Medical Centre

Melbourne, , Australia

The Alfred Hospital

Melbourne, , Australia

Fiona Stanley Hospital Perth

Perth, , Australia

Universitair Ziekenhuis Antwerpen

Antwerp, , Belgium

London Health Sciences Centre - University Campus

London, , Canada

Sunnybrook Health Sciences Center

Toronto, , Canada

Saint Paul's Hospital

Vancouver, , Canada

Angiografia de Occidente S.A.

Cali, , Colombia

Nemocnice Podlesi a.s.

Třinec, , Czechia

Centre Hospitalier Universitaire - Hopital Henri Mondor

Créteil, , France

Centre Hospitalier Regional Universitaire de Lille

Lille, , France

Institut Hospitalier Jacques Cartier

Massy, , France

Hopital Bichat - Claude Bernard

Paris, , France

Clinique Pasteur

Toulouse, , France

Herz- und Diabeteszentrum NRW - Ruhr-Universitaet Bochum

Bad Oeynhausen, , Germany

Deutsches Herzzentrum Berlin

Berlin, , Germany

University of Bonn, Cardiology

Bonn, , Germany

Sana-Herzzentrum Cottbus GmbH

Cottbus, , Germany

Herzzentrum Dresden GmbH Universitaetsklinik

Dresden, , Germany

Universitaetsklinikum Düsseldorf

Düsseldorf, , Germany

Elisabeth-Krankenhaus Essen GmbH

Essen, , Germany

Universitätsklinikum Essen

Essen, , Germany

University of Frankfurt

Frankfurt, , Germany

Asklepios Klinik Sankt Georg

Hamburg, , Germany

Städtisches Klinikum Karlsruhe GmbH

Karlsruhe, , Germany

Herzzentrum Leipzig GmbH

Leipzig, , Germany

Deutsches Herzzentrum Muenchen - Klinik an der TU Muenchen

Munich, , Germany

Hygeia Hospital

Athens, , Greece

Semmelweis Egyetem AOK

Budapest, , Hungary

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, , Italy

Presidio Ospedaliero Ferrarotto Alessi

Catania, , Italy

IRCCS Policlinico San Donato

Milan, , Italy

Ospedale San Raffaele - Milano

Milan, , Italy

Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

Pisa, , Italy

Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark

Amsterdam, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Oslo Universitetssykehus-Ullevål Universitetssykehus

Oslo, , Norway

Complejo Hospitalario Dr Arnulfo Arias Madrid

Panama City, , Panama

Instytut Kardiologii

Warsaw, , Poland

Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I

Vila Nova de Gaia, , Portugal

Prince Sultan Cardiac Center

Riyadh, , Saudi Arabia

Mediclinic Panorama

Cape Town, , South Africa

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Hospital Universitario Central de Asturias

Oviedo, , Spain

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, , Spain

Akademiska Sjukhuset

Uppsala, , Sweden

Royal Victoria Hospital - Belfast Health and Social Care Trust

Belfast, , United Kingdom

Royal Sussex County Hospital

Brighton, , United Kingdom

The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary

Leeds, , United Kingdom

The Royal Wolverhampton Hospitals NHS - New Cross Hospital

Wolverhampton, , United Kingdom

Countries

Australia; Belgium; Canada; Colombia; Czechia; France; Germany; Greece; Hungary; Israel; Italy; Netherlands; Norway; Panama; Poland; Portugal; Saudi Arabia; South Africa; Spain; Sweden; United Kingdom

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Informed Consent Form

View Document

Document Type: Informed Consent Form: Data Release Form

View Document

Other Identifiers

Evolut R™ FORWARD Study

Identifier Type: -

Identifier Source: org_study_id