Aortic Valve StenosisNCT03417011
FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System
An observational study of Aortic Valve Stenosis, run by Medtronic Cardiovascular at 39 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)
- Type of treatment
- Medical device
- How many people
- 638 participants
- Where
- 39 sitesin 14 countries
- Study dates
- 26 Feb 2018to 26 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
39 sites in 14 countries.
39 sites in 14 countries
Germany11 sites
Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
Bad Oeynhausen
Deutsches Herzzentrum Berlin
Berlin
Universitätsklinikum Bonn
Bonn
Sana-Herzzentrum Cottbus GmbH
Cottbus
Herzzentrum Dresden GmbH Universitätsklinik
Dresden
Universitätsklinikum Düsseldorf
Düsseldorf
Universitätsklinikum Essen
Essen
Asklepios Klinik St. Georg
Hamburg
Herzzentrum Leipzig GmbH
Leipzig
Deutsches Herzzentrum München Klinik an der TU München
Munich
SANA Herzchirurgie Stuttgart GmbH
Stuttgart
Italy5 sites
Azienda Ospedaliera Spedali Civili di Brescia
Brescia
AOU Presidio Gaspare Rodolico Policlinico
Catania
Azienda Ospedaliera Ospedale Niguarda Cà Granda
Milan
IRCCS Policlinico San Donato
Milan
Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello
Pisa
France3 sites
CHU Bordeaux
Bordeaux
Hôpital Henri Mondor
Créteil
Clinique Pasteur
Toulouse
Netherlands3 sites
Onze Lieve Vrouwe Gasthuis
Amsterdam
Catharina Ziekenhuis Eindhoven
Eindhoven
Erasmus Medisch Centrum
Rotterdam
Spain3 sites
Hospital Universitario Virgen de la Victoria
Málaga
Hospital Universitario Central de Asturias
Oviedo
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela
United Kingdom3 sites
Royal Victoria Hospital - Belfast Health and Social Care Trust
Belfast
St. George's Hospital
London
The Royal Wolverhampton Hospitals NHS - New Cross Hospital
Wolverhampton
Belgium2 sites
Universitair Ziekenhuis Antwerpen
Antwerp
CHU de Liège - Hôpital du Sart Tilman
Liège
Israel2 sites
Hadassah Medical Organisation
Jerusalem
Rabin Medical Center - Beilinson Hospital
Petah Tikva
Switzerland2 sites
Inselspital - Universitätsspital
Bern
Universtitätsspital Zürich
Zurich
About this study
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.
Read the 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
- Being tested
- Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)Device
Transcatheter Aortic Valve Replacement with Medtronic Evolut PRO system
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
The all-cause mortality rate at 30 days post procedure meets a prespecified performance goal of 5.5%.
Measured: 30 days post procedure
Secondary outcomes (10)
Total AR
The percentage of subjects graded as none or trace total aortic regurgitation at discharge is greater than a prespecified performance goal of 67.1%.
Measured: 24 hours to 7 days post procedure (prior to discharge)
VARC-2 composite safety endpoint
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)
Measured: through 5 years from enrollment until end of study
Individual components of the VARC-2 composite safety endpoint
Event rates of the individual components of the VARC-2 composite safety endpoint through 5 years until end of study
Measured: through 5 years from enrollment until end of study
Rate of new permanent pacemaker implant
Rate of new permanent pacemaker implant at 30 days post procedure
Measured: 30 days post procedure
Device success rate
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.
Measured: 24 hours to 7 days post procedure (prior to discharge)
Hemodynamic performance
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.
Measured: 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post
Hemodynamic performance
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.
Measured: 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post
Hemodynamic performance
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.
Measured: 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post
Change in NYHA functional status
Change in NYHA functional status from baseline to 30-day, 1-year, 3-year, and 5-year post procedure
Measured: From baseline to 30-day, 1-year, 3-year, and 5-year post procedure
Change in Quality of Life score
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.
Measured: From baseline to 30-day, and 1-year, 3-year, and 5-year post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start26 Feb 2018
- Primary completion6 Mar 2019
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 638 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417011
- Sponsor's protocol ID
- MDT17050EVR003
- Status last verified
- Sep 2025
- First submitted
- 18 Jan 2018
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39686582Manoharan 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.
PubMed 32748789
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System
- ClinicalTrials.gov ID
- NCT03417011
- Acronym / sponsor ID
- MDT17050EVR003
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 638 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)Transcatheter Aortic Valve Replacement with Medtronic Evolut PRO system | Device | – |
Primary outcome
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%.
10 secondary outcomes
Total AR
Time frame: 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
Individual components of the VARC-2 composite safety endpoint
Time frame: through 5 years from enrollment until end of study
Rate of new permanent pacemaker implant
Time frame: 30 days post procedure
Device success rate
Time frame: 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
Time frame: 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
Change in NYHA functional status
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Derived from this study: PubMed 39686582Van 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.
- Derived from this study: PubMed 32748789Manoharan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
39 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Medtronic Cardiovascular at 39 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Germany, Italy, France, Netherlands, Spain and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 30 days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03417011, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.