Aortic Valve Stenosis Clinical Trial
Official title:
FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System
Verified date | May 2024 |
Source | Medtronic Cardiovascular |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 638 |
Est. completion date | February 26, 2024 |
Est. primary completion date | March 6, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | LKH - Universitätsklinikum | Graz | |
Belgium | Universitair Ziekenhuis Antwerpen | Antwerp | |
Belgium | CHU de Liège - Hôpital du Sart Tilman | Liège | |
Denmark | Rigshospitalet | Copenhagen | |
Finland | Turun Yliopistollinen Keskussairaala | Turku | |
France | CHU Bordeaux | Bordeaux | |
France | Hôpital Henri Mondor | Créteil | |
France | Clinique Pasteur | Toulouse | |
Germany | 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 | Dusseldorf | |
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 | |
Israel | Hadassah Medical Organisation | Jerusalem | |
Israel | Rabin Medical Center - Beilinson Hospital | Petah tikva | |
Italy | 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 | |
Netherlands | Onze Lieve Vrouwe Gasthuis | Amsterdam | |
Netherlands | Catharina Ziekenhuis Eindhoven | Eindhoven | |
Netherlands | Erasmus Medisch Centrum | Rotterdam | |
Norway | Oslo Universitetssykehus-Ullevål | Oslo | |
Slovenia | University Medical Centre | Ljubljana | |
Spain | 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 | |
Switzerland | Inselspital - Universitätsspital | Bern | |
Switzerland | Universtitätsspital Zürich | Zürich | |
United Kingdom | 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 |
Lead Sponsor | Collaborator |
---|---|
Medtronic Cardiovascular |
Austria, Belgium, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Norway, Slovenia, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | 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) |
through 5 years from enrollment until end of study | |
Secondary | 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 | |
Secondary | Rate of new permanent pacemaker implant | Rate of new permanent pacemaker implant at 30 days post procedure | 30 days post procedure | |
Secondary | 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. |
24 hours to 7 days post procedure (prior to discharge) | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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