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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System) | Device | Transcatheter Aortic Valve Replacement with Medtronic Evolut PRO system |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | 24 hours to 7 days post procedure (prior to discharge) |
| VARC-2 composite safety endpoint |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH - Universitätsklinikum | Graz | Austria | ||||
| Universitair Ziekenhuis Antwerpen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39686582 | Derived | 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. | |
| 32748789 |
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Event rate of the VARC-2 composite safety endpoint through 5 years from enrollment until end of study, which includes the following components:
| 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 | 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 | 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:
| 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. | 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. | 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. | 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 | 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. | From baseline to 30-day, and 1-year, 3-year, and 5-year post procedure |
| 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 |
| 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. |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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