Clinical trial NCT02592369: CoreValve™ Evolut R™ FORWARD Study
Official title: The Medtronic CoreValve™ Evolut R™ FORWARD Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2015-10-30
Enrollment: 1060
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population includes patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement who are scheduled for an elective transcatheter aortic valve implantation. Patients who will undergo an emergency procedure should not be included in this study.

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.

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

Primary outcomes:
measure: All-cause mortality rate
timeFrame: 30 days post implant
Secondary outcomes:
measure: Device success according to VARC2
timeFrame: 24h to 7 days post implant
measure: Hemodynamic performance
timeFrame: 24h to 7 days and 1 year post implant
measure: Hemodynamic performance
timeFrame: 24h to 7 days and 1 year post implant
measure: Hemodynamic performance
timeFrame: 24h to 7 days and 1 year post implant
measure: Early safety composite endpoint according to VARC2
timeFrame: 30 days post implant
measure: Event rates according to VARC2
timeFrame: 30 days post implant
measure: Rate of new permanent pacemaker implant
timeFrame: 30 days post implant
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Flinders Medical Centre
city: Melbourne
country: Australia
facility: Monash Medical Centre
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Perth
country: Australia
facility: Fiona Stanley Hospital Perth
city: Antwerpen
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: London
country: Canada
facility: London Health Sciences Centre - University Campus
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
city: Vancouver
country: Canada
facility: Saint Paul's Hospital
city: Cali
country: Colombia
facility: Angiografia de Occidente S.A.
city: Trinec
country: Czechia
facility: Nemocnice Podlesi a.s.
city: Creteil
country: France
facility: Centre Hospitalier Universitaire - Hopital Henri Mondor
city: Lille
country: France
facility: Centre Hospitalier Regional Universitaire de Lille
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier
city: Paris
country: France
facility: Hopital Bichat - Claude Bernard
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW - Ruhr-Universitaet Bochum
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Bonn
country: Germany
facility: University of Bonn, Cardiology
city: Cottbus
country: Germany
facility: Sana-Herzzentrum Cottbus GmbH
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitaetsklinik
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Düsseldorf
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen GmbH
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt
country: Germany
facility: University of Frankfurt
city: Hamburg
country: Germany
facility: Asklepios Klinik Sankt Georg
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe GmbH
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen - Klinik an der TU Muenchen
city: Athens
country: Greece
facility: Hygeia Hospital
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK
city: Tel-Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Catania
country: Italy
facility: Presidio Ospedaliero Ferrarotto Alessi
city: Milan
country: Italy
facility: IRCCS Policlinico San Donato
city: Milan
country: Italy
facility: Ospedale San Raffaele - Milano
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Oslo
country: Norway
facility: Oslo Universitetssykehus-Ullevål Universitetssykehus
city: Panama
country: Panama
facility: Complejo Hospitalario Dr Arnulfo Arias Madrid
city: Warsaw
country: Poland
facility: Instytut Kardiologii
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I
city: Riyadh
country: Saudi Arabia
facility: Prince Sultan Cardiac Center
city: Cape Town
country: South Africa
facility: Mediclinic Panorama
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital - Belfast Health and Social Care Trust
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton Hospitals NHS - New Cross Hospital
Study officials:
affiliation: University Hospital, Bonn
name: Eberhard Grube, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: INSELSPITAL, Universitätsspital Bern
name: Stephan Windecker, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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