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

September 8, 2025 updated by: Medtronic Cardiovascular

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
638

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • LKH - Universitätsklinikum
  • Belgium
      • Antwerp, Belgium
        • Universitair Ziekenhuis Antwerpen
      • Liège, Belgium
        • CHU de Liège - Hôpital du Sart Tilman
  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet
  • Finland
      • Turku, Finland
        • Turun yliopistollinen keskussairaala
  • France
      • Bordeaux, France
        • CHU Bordeaux
      • Créteil, France
        • Hôpital Henri Mondor
      • Toulouse, France
        • Clinique Pasteur
  • Germany
      • Bad Oeynhausen, Germany
        • Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
      • Berlin, Germany
        • Deutsches Herzzentrum Berlin
      • Bonn, Germany
        • Universitatsklinikum Bonn
      • Cottbus, Germany
        • Sana-Herzzentrum Cottbus GmbH
      • Dresden, Germany
        • Herzzentrum Dresden GmbH Universitätsklinik
      • Düsseldorf, Germany
        • Universitätsklinikum Düsseldorf
      • Essen, Germany
        • Universitätsklinikum Essen
      • Hamburg, Germany
        • Asklepios Klinik St. Georg
      • Leipzig, Germany
        • Herzzentrum Leipzig GmbH
      • Munich, Germany
        • Deutsches Herzzentrum München Klinik an der TU München
      • Stuttgart, Germany
        • Sana Herzchirurgie Stuttgart GmbH
  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organisation
      • Petah Tikva, Israel
        • Rabin Medical Center - Beilinson Hospital
  • Italy
      • Brescia, Italy
        • Azienda Ospedaliera Spedali Civili di Brescia
      • Catania, Italy
        • AOU Presidio Gaspare Rodolico Policlinico
      • Milan, Italy
        • Azienda Ospedaliera Ospedale Niguarda Ca Granda
      • Milan, Italy
        • IRCCS Policlinico San Donato
      • Pisa, Italy
        • Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello
  • Netherlands
      • Amsterdam, Netherlands
        • Onze Lieve Vrouwe Gasthuis
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis Eindhoven
      • Rotterdam, Netherlands
        • Erasmus Medisch Centrum
  • Norway
      • Oslo, Norway
        • Oslo Universitetssykehus-Ullevål
  • Slovenia
      • Ljubljana, Slovenia
        • University Medical Centre
  • Spain
      • Málaga, Spain
        • Hospital Universitario Virgen de la Victoria
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias
      • Santiago de Compostela, Spain
        • Complejo Hospitalario Universitario de Santiago de Compostela
  • Switzerland
      • Bern, Switzerland
        • Inselspital - Universitätsspital
      • Zurich, Switzerland
        • Universtitätsspital Zürich
  • United Kingdom
      • Belfast, United Kingdom
        • Royal Victoria Hospital - Belfast Health and Social Care Trust
      • London, United Kingdom
        • St. George's Hospital
      • Wolverhampton, United Kingdom
        • The Royal Wolverhampton Hospitals NHS - New Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 30 days post procedure
The all-cause mortality rate at 30 days post procedure meets a prespecified performance goal of 5.5%.
30 days post procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total AR
Time Frame: 24 hours to 7 days post procedure (prior to discharge)
The percentage of subjects graded as none or trace total aortic regurgitation at discharge is greater than a prespecified performance goal of 67.1%.
24 hours to 7 days post procedure (prior to discharge)
VARC-2 composite safety endpoint
Time Frame: through 5 years from enrollment until end of study

Event rate of the VARC-2 composite safety endpoint through 5 years from enrollment until end of study, which includes the following components:

  • All-cause mortality
  • All stroke (disabling and non-disabling)
  • Life-threatening bleeding
  • Acute kidney injury: stage 2 or 3 (including renal replacement therapy)
  • Coronary artery obstruction requiring intervention
  • Major vascular complication
  • Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)
through 5 years from enrollment until end of study
Individual components of the VARC-2 composite safety endpoint
Time Frame: through 5 years from enrollment until end of study
Event rates of the individual components of the VARC-2 composite safety endpoint through 5 years until end of study
through 5 years from enrollment until end of study
Rate of new permanent pacemaker implant
Time Frame: 30 days post procedure
Rate of new permanent pacemaker implant at 30 days post procedure
30 days post procedure
Device success rate
Time Frame: 24 hours to 7 days post procedure (prior to discharge)

Device success rate at 24 hours to 7 days post procedure (prior to discharge), defined according to the VARC-2 guidelines as:

  • Absence of procedural mortality, AND
  • Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND
  • Intended performance of the prosthetic heart valve, defined as the absence of patient prosthesis mismatch and mean gradient <20 mmHg (or peak velocity <3 m/sec), AND
  • No moderate or severe prosthetic valve regurgitation.
24 hours to 7 days post procedure (prior to discharge)
Hemodynamic performance
Time Frame: 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post
Hemodynamic performance at 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post procedure, including the mean prosthetic valve gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.
24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post
Hemodynamic performance
Time Frame: 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post
Hemodynamic performance at 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post procedure, including the effective orifice area as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.
24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post
Hemodynamic performance
Time Frame: 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post
Hemodynamic performance at 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post procedure, including the degree of prosthetic valve regurgitation (transvalvular, paravalvular and total) as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.
24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post
Change in NYHA functional status
Time Frame: From baseline to 30-day, 1-year, 3-year, and 5-year post procedure
Change in NYHA functional status from baseline to 30-day, 1-year, 3-year, and 5-year post procedure
From baseline to 30-day, 1-year, 3-year, and 5-year post procedure
Change in Quality of Life score
Time Frame: From baseline to 30-day, and 1-year, 3-year, and 5-year post procedure
Change in Quality of Life score (EQ-5D questionnaire) from baseline to 30-day, and 1-year, 3-year, and 5-year post procedure. The EQ-5D descriptive system comprises five dimensions and each dimension has five levels of severity. The subject is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the five dimensions. The EQ VAS records the subject's self-rated health on a 20 cm vertical, visual analogue scale. The subject marks an X on the scale to indicate how his/her health is TODAY and then writes the number they marked on the scale in the box below.
From baseline to 30-day, and 1-year, 3-year, and 5-year post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiovascular

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 6, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MDT17050EVR003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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