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

NCT03417011 | Completed

• 1 other identifier: MDT17050EVR003
• Study Type: observational
• Target: 638
• Locations: 14 countries
• Sites: 39

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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  The all-cause mortality rate at 30 days post procedure meets a prespecified performance goal of 5.5%.

  30 days post procedure

Secondary Outcomes (10)

• Total AR

  24 hours to 7 days post procedure (prior to discharge)

• VARC-2 composite safety endpoint

  through 5 years from enrollment until end of study

• Individual components of the VARC-2 composite safety endpoint

  through 5 years from enrollment until end of study

• Rate of new permanent pacemaker implant

  30 days post procedure

• Device success rate

  24 hours to 7 days post procedure (prior to discharge)

Interventions

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

Transcatheter Aortic Valve Replacement with Medtronic Evolut PRO system

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (39)

LKH - Universitätsklinikum

Graz, Austria

Location

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Location

CHU de Liège - Hôpital du Sart Tilman

Liège, Belgium

Location

Rigshospitalet

Copenhagen, Denmark

Location

Turun Yliopistollinen Keskussairaala

Turku, Finland

Location

CHU Bordeaux

Bordeaux, France

Location

Hôpital Henri Mondor

Créteil, France

Location

Clinique Pasteur

Toulouse, France

Location

Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

Bad Oeynhausen, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, Germany

Location

Universitätsklinikum Bonn

Bonn, Germany

Location

Sana-Herzzentrum Cottbus GmbH

Cottbus, Germany

Location

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

Asklepios Klinik St. Georg

Hamburg, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, Germany

Location

Deutsches Herzzentrum München Klinik an der TU München

Munich, Germany

Location

SANA Herzchirurgie Stuttgart GmbH

Stuttgart, Germany

Location

Hadassah Medical Organisation

Jerusalem, Israel

Location

Rabin Medical Center - Beilinson Hospital

Petah Tikva, Israel

Location

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy

Location

AOU Presidio Gaspare Rodolico Policlinico

Catania, Italy

Location

Azienda Ospedaliera Ospedale Niguarda Cà Granda

Milan, Italy

Location

IRCCS Policlinico San Donato

Milan, Italy

Location

Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

Pisa, Italy

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

Catharina Ziekenhuis Eindhoven

Eindhoven, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, Netherlands

Location

Oslo Universitetssykehus-Ullevål

Oslo, Norway

Location

University Medical Centre

Ljubljana, Slovenia

Location

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Location

Inselspital - Universitätsspital

Bern, Switzerland

Location

Universtitätsspital Zürich

Zurich, Switzerland

Location

Royal Victoria Hospital - Belfast Health and Social Care Trust

Belfast, United Kingdom

Location

St. George's Hospital

London, United Kingdom

Location

The Royal Wolverhampton Hospitals NHS - New Cross Hospital

Wolverhampton, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 39686582 DERIVED

• 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.

  PMID: 32748789 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 31, 2018
• Study Start: February 26, 2018
• Primary Completion: March 6, 2019
• Study Completion: February 26, 2024
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); ES (3); FI (1); DE (11); IT (5); CH (2); GB (3); IL (2); SL (1); BE (2); DK (1); AU (1); FR (3); NL (3)