CoreValve™ Evolut R™ FORWARD Study

Aortic Valve Stenosis Clinical Trial

— FORWARD  

Official title:

The Medtronic CoreValve™ Evolut R™ FORWARD Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592369
• Other study ID #: Evolut R™ FORWARD Study
• Status: Completed
• Start date: January 2016
• Est. completion date: February 6, 2020

Study information

• Verified date: April 2020
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

Description:

The study objective is to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

Prospective, single arm, multi-center, observational, post market study. In Australia and Canada it is a prospective, single arm, multi-center pre-market study.

Up to 60 centers worldwide. Geographies may include Europe, Australia, Middle East and Africa, Latin America and Canada.

Approximately 1000 implanted subjects, consented for follow-up through three years.

For each subject, data will be collected preoperatively, intra-operatively, at hospital discharge, 30 days, 1, 2 and 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1060
• Est. completion date: February 6, 2020
• Est. primary completion date: February 2017
• 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

• Acceptable candidate for elective treatment with the Evolut R System and in conformity with the local regulatory and medico economic context

• Age =80 years OR considered to be at high or greater risk for surgical aortic valve replacement (AVR) where high risk is defined as:

• Society of Thoracic Surgeons (STS) predicted risk of mortality =8% OR

• Documented heart team agreement of risk for AVR due to frailty or comorbidities.

• Geographically stable and willing to return to the implanting site for all follow-up visits

• Of legal age to provide informed consent (patient Informed Consent or Data Release Form) in the country where they enroll in the trial

• The patient has been informed of the nature of the study, is able and willing to provide consent without assistance from a legal representative and has consented to participate, and has authorized the collection and release of his/her medical information by signing a Patient Informed Consent or Data Release Form.

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 R system

• Estimated life expectancy of less than 1 year

• Participating in another trial that may influence the outcome of this trial

• Need for emergency surgery for any reason

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Medtronic CoreValve™ Evolut R™ System
The Evolut R System is intended for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, to be at high or extreme risk for open heart surgery. The Evolut R TAV treats aortic stenosis by displacing and functionally replacing the dysfunctional native valve with a bioprosthetic valve delivered on a catheter while the heart is still beating, thus avoiding the risks of cardiopulmonary bypass. Its intended performance is to relieve aortic valve stenosis without inducing significant regurgitation, thereby restoring effective aortic valve function.

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Adelaide
Australia	Monash Medical Centre	Melbourne
Australia	The Alfred Hospital	Melbourne
Australia	Fiona Stanley Hospital Perth	Perth
Belgium	Universitair Ziekenhuis Antwerpen	Antwerpen
Canada	London Health Sciences Centre - University Campus	London
Canada	Sunnybrook Health Sciences Center	Toronto
Canada	Saint Paul's Hospital	Vancouver
Colombia	Angiografia de Occidente S.A.	Cali
Czechia	Nemocnice Podlesi a.s.	Trinec
France	Centre Hospitalier Universitaire - Hopital Henri Mondor	Creteil
France	Centre Hospitalier Regional Universitaire de Lille	Lille
France	Institut Hospitalier Jacques Cartier	Massy
France	Hopital Bichat - Claude Bernard	Paris
France	Clinique Pasteur	Toulouse
Germany	Herz- und Diabeteszentrum NRW - Ruhr-Universitaet Bochum	Bad Oeynhausen
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	University of Bonn, Cardiology	Bonn
Germany	Sana-Herzzentrum Cottbus GmbH	Cottbus
Germany	Herzzentrum Dresden GmbH Universitaetsklinik	Dresden
Germany	Universitaetsklinikum Düsseldorf	Duesseldorf
Germany	Elisabeth-Krankenhaus Essen GmbH	Essen
Germany	Universitätsklinikum Essen	Essen
Germany	University of Frankfurt	Frankfurt
Germany	Asklepios Klinik Sankt Georg	Hamburg
Germany	Städtisches Klinikum Karlsruhe GmbH	Karlsruhe
Germany	Herzzentrum Leipzig GmbH	Leipzig
Germany	Deutsches Herzzentrum Muenchen - Klinik an der TU Muenchen	Munich
Greece	Hygeia Hospital	Athens
Hungary	Semmelweis Egyetem AOK	Budapest
Israel	Tel Aviv Sourasky Medical Center	Tel-Aviv
Italy	Azienda Ospedaliera Spedali Civili di Brescia	Brescia
Italy	Presidio Ospedaliero Ferrarotto Alessi	Catania
Italy	IRCCS Policlinico San Donato	Milan
Italy	Ospedale San Raffaele - Milano	Milan
Italy	Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello	Pisa
Netherlands	Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark	Amsterdam
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	Erasmus Medisch Centrum	Rotterdam
Norway	Oslo Universitetssykehus-Ullevål Universitetssykehus	Oslo
Panama	Complejo Hospitalario Dr Arnulfo Arias Madrid	Panama
Poland	Instytut Kardiologii	Warsaw
Portugal	Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I	Vila Nova de Gaia
Saudi Arabia	Prince Sultan Cardiac Center	Riyadh
South Africa	Mediclinic Panorama	Cape Town
Spain	Hospital Universitario Virgen de la Victoria	Malaga
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Complejo Hospitalario Universitario de Santiago de Compostela	Santiago de Compostela
Sweden	Akademiska Sjukhuset	Uppsala
United Kingdom	Royal Victoria Hospital - Belfast Health and Social Care Trust	Belfast
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary	Leeds
United Kingdom	The Royal Wolverhampton Hospitals NHS - New Cross Hospital	Wolverhampton

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

Australia,  Belgium,  Canada,  Colombia,  Czechia,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Netherlands,  Norway,  Panama,  Poland,  Portugal,  Saudi Arabia,  South Africa,  Spain,  Sweden,  United Kingdom, 

References & Publications (27)

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Nuis RJ, Van Mieghem NM, Schultz CJ, Moelker A, van der Boon RM, van Geuns RJ, van der Lugt A, Serruys PW, Rodés-Cabau J, van Domburg RT, Koudstaal PJ, de Jaegere PP. Frequency and causes of stroke during or after transcatheter aortic valve implantation. — View Citation

Piazza N, Nuis RJ, Tzikas A, Otten A, Onuma Y, García-García H, Schultz C, van Domburg R, van Es GA, van Geuns R, de Jaegere P, Serruys PW. Persistent conduction abnormalities and requirements for pacemaking six months after transcatheter aortic valve imp — View Citation

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality rate	All-cause mortality rate at 30 days post procedure	30 days post implant
Secondary	Device success according to VARC2	Device success rate at 24 hours to 7 days, defined according to the Valve Academic Research Consortium-2 (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.	24h to 7 days post implant
Secondary	Hemodynamic performance	Hemodynamic performance at 24 hours to 7 days (discharge) and 1 year post procedure, including the mean prosthetic valve gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.	24h to 7 days and 1 year post implant
Secondary	Hemodynamic performance	Hemodynamic performance at 24 hours to 7 days (discharge) and 1 year post procedure, including the effective orifice area as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.	24h to 7 days and 1 year post implant
Secondary	Hemodynamic performance	Hemodynamic performance at 24 hours to 7 days (discharge) and 1 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.	24h to 7 days and 1 year post implant
Secondary	Early safety composite endpoint according to VARC2	Early Safety composite endpoint at 30 days post procedure, defined according to the VARC-2 guidelines, defined as any of 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)	30 days post implant
Secondary	Event rates according to VARC2	Event rates of the individual components of the VARC-2 composite Early Safety endpoint at 30 days post procedure	30 days post implant
Secondary	Rate of new permanent pacemaker implant	Rate of new permanent pacemaker implant at 30 days post procedure	30 days post implant