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

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03417011
• Other study ID #: MDT17050EVR003
• Status: Completed
• Start date: February 26, 2018
• Est. completion date: February 26, 2024

Study information

• Verified date: May 2024
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)
Transcatheter Aortic Valve Replacement with Medtronic Evolut PRO system

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Finland,  France,  Germany,  Israel,  Italy,  Netherlands,  Norway,  Slovenia,  Spain,  Switzerland,  United Kingdom, 

Outcome

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