FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System

NCT ID: NCT03417011

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 638 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-26
• Study Completion Date: 2024-02-26

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.

Conditions

Aortic Valve Stenosis

Study Design

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

Interventions

Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)

Transcatheter Aortic Valve Replacement with Medtronic Evolut PRO system

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
• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LKH - Universitätsklinikum

Graz, , Austria

Universitair Ziekenhuis Antwerpen

Antwerp, , Belgium

CHU de Liège - Hôpital du Sart Tilman

Liège, , Belgium

Rigshospitalet

Copenhagen, , Denmark

Turun Yliopistollinen Keskussairaala

Turku, , Finland

CHU Bordeaux

Bordeaux, , France

Hôpital Henri Mondor

Créteil, , France

Clinique Pasteur

Toulouse, , France

Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

Bad Oeynhausen, , Germany

Deutsches Herzzentrum Berlin

Berlin, , Germany

Universitätsklinikum Bonn

Bonn, , Germany

Sana-Herzzentrum Cottbus GmbH

Cottbus, , Germany

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, , Germany

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Universitätsklinikum Essen

Essen, , Germany

Asklepios Klinik St. Georg

Hamburg, , Germany

Herzzentrum Leipzig GmbH

Leipzig, , Germany

Deutsches Herzzentrum München Klinik an der TU München

Munich, , Germany

SANA Herzchirurgie Stuttgart GmbH

Stuttgart, , Germany

Hadassah Medical Organisation

Jerusalem, , Israel

Rabin Medical Center - Beilinson Hospital

Petah Tikva, , Israel

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, , Italy

AOU Presidio Gaspare Rodolico Policlinico

Catania, , Italy

Azienda Ospedaliera Ospedale Niguarda Cà Granda

Milan, , Italy

IRCCS Policlinico San Donato

Milan, , Italy

Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

Pisa, , Italy

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Catharina Ziekenhuis Eindhoven

Eindhoven, , Netherlands

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Oslo Universitetssykehus-Ullevål

Oslo, , Norway

University Medical Centre

Ljubljana, , Slovenia

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

Inselspital - Universitätsspital

Bern, , Switzerland

Universtitätsspital Zürich

Zurich, , Switzerland

Royal Victoria Hospital - Belfast Health and Social Care Trust

Belfast, , United Kingdom

St. George's Hospital

London, , United Kingdom

The Royal Wolverhampton Hospitals NHS - New Cross Hospital

Wolverhampton, , United Kingdom

Countries

Austria; Belgium; Denmark; Finland; France; Germany; Israel; Italy; Netherlands; Norway; Slovenia; Spain; Switzerland; United Kingdom

References

Van Mieghem NM, Windecker S, Manoharan G, Lancellotti P, Tamburino C, Kornowski R, Thiele H, Danenberg H, Fiorina C, Scholtz W, Brecker S, Ruge H, Opdahl A, Amoroso G, Bedogni F, Petronio AS, Nickenig G, Harnath A, Kempfert J, Oh JK, Eisenberg RE, Grube E. Three-Year Outcomes With a Supra-Annular, Self-Expanding Bioprosthesis and a Pericardial Wrap-The FORWARD PRO Study. Catheter Cardiovasc Interv. 2025 Feb;105(3):577-587. doi: 10.1002/ccd.31335. Epub 2024 Dec 16.

Reference Type: DERIVED

PMID: 39686582 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32748789 (View on PubMed)

Other Identifiers

MDT17050EVR003

Identifier Type: -

Identifier Source: org_study_id