Clinical trial NCT03417011: FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System
Official title: FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2018-01-31
Enrollment: 638
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.

Brief summary: Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system.

The investigation purpose is to evaluate the acute and long term clinical performance and safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.

Detailed description: Approximately 600 subjects implanted with the Evolut™ PRO at up to 40 sites in Europe. Other regions may be added depending on the regulatory status of the device.

Eligibility criteria: Inclusion Criteria:

* Symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement
* High or greater risk for surgical aortic valve replacement as estimated by the heart team OR, 75 years or older and at intermediate risk for surgical AVR (STS risk score ≥4% or with an estimated hospital mortality ≥4% as assessed by the heart team)
* Acceptable candidate for treatment with the Evolut™ PRO system in conformity with the Instructions for Use and the local regulations
* Able and willing to return to the implanting site at the following follow-up visits: 1-year, 3-year and 5-year
* Written informed consent obtained without assistance from a legal representative prior to enrollment in the study.

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™ PRO system
* Estimated life expectancy of less than 1 year
* Participating in another trial that may influence the outcome of this study
* Need for emergency surgery for any reason
* Inability to understand and respond to the quality of life questionnaire

Primary outcomes:
measure: All-cause mortality
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Total AR
timeFrame: 24 hours to 7 days post procedure (prior to discharge)
measure: VARC-2 composite safety endpoint
timeFrame: through 5 years from enrollment until end of study
measure: Individual components of the VARC-2 composite safety endpoint
timeFrame: through 5 years from enrollment until end of study
measure: Rate of new permanent pacemaker implant
timeFrame: 30 days post procedure
measure: Device success rate
timeFrame: 24 hours to 7 days post procedure (prior to discharge)
measure: Hemodynamic performance
timeFrame: 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post
measure: Hemodynamic performance
timeFrame: 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post
measure: Hemodynamic performance
timeFrame: 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post
measure: Change in NYHA functional status
timeFrame: From baseline to 30-day, 1-year, 3-year, and 5-year post procedure
measure: Change in Quality of Life score
timeFrame: From baseline to 30-day, and 1-year, 3-year, and 5-year post procedure
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH - Universitätsklinikum
city: Antwerp
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Liège
country: Belgium
facility: CHU de Liège - Hôpital du Sart Tilman
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Turku
country: Finland
facility: Turun Yliopistollinen Keskussairaala
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Cottbus
country: Germany
facility: Sana-Herzzentrum Cottbus GmbH
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
city: Dusseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Munich
country: Germany
facility: Deutsches Herzzentrum München Klinik an der TU München
city: Stuttgart
country: Germany
facility: SANA Herzchirurgie Stuttgart GmbH
city: Jerusalem
country: Israel
facility: Hadassah Medical Organisation
city: Petah tikva
country: Israel
facility: Rabin Medical Center - Beilinson Hospital
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Catania
country: Italy
facility: AOU Presidio Gaspare Rodolico Policlinico
city: Milan
country: Italy
facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda
city: Milan
country: Italy
facility: IRCCS Policlinico San Donato
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis Eindhoven
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Oslo
country: Norway
facility: Oslo Universitetssykehus-Ullevål
city: Ljubljana
country: Slovenia
facility: University Medical Centre
city: Málaga
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: Bern
country: Switzerland
facility: Inselspital - Universitätsspital
city: Zürich
country: Switzerland
facility: Universtitätsspital Zürich
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital - Belfast Health and Social Care Trust
city: London
country: United Kingdom
facility: St. George's Hospital
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton Hospitals NHS - New Cross Hospital
Study officials:
References:
citation: Manoharan G, Grube E, Van Mieghem NM, Brecker S, Fiorina C, Kornowski R, Danenberg H, Ruge H, Thiele H, Lancellotti P, Sondergaard L, Tamburino C, Oh JK, Fan Y, Windecker S. Thirty-day clinical outcomes of the Evolut PRO self-expanding transcatheter aortic valve: the international FORWARD PRO study. EuroIntervention. 2020 Nov 20;16(10):850-857. doi: 10.4244/EIJ-D-20-00279.