CoreValve™ Evolut R™ FORWARD Study

NCT02592369 | Completed

• 1 other identifier: Evolut R™ FORWARD Study
• Study Type: observational
• Target: 1,060
• Locations: 21 countries
• Sites: 54

Brief 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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• All-cause mortality rate

  All-cause mortality rate at 30 days post procedure

  30 days post implant

Secondary Outcomes (7)

• Device success according to VARC2

  24h to 7 days post implant

• Hemodynamic performance

  24h to 7 days and 1 year post implant

• Hemodynamic performance

  24h to 7 days and 1 year post implant

• Hemodynamic performance

  24h to 7 days and 1 year post implant

• Early safety composite endpoint according to VARC2

  30 days post implant

Interventions

Medtronic CoreValve™ Evolut R™ System DEVICE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population includes patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement who are scheduled for an elective transcatheter aortic valve implantation. Patients who will undergo an emergency procedure should not be included in this study.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (54)

Flinders Medical Centre

Adelaide, Australia

Location

Monash Medical Centre

Melbourne, Australia

Location

The Alfred Hospital

Melbourne, Australia

Location

Fiona Stanley Hospital Perth

Perth, Australia

Location

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Location

London Health Sciences Centre - University Campus

London, Canada

Location

Sunnybrook Health Sciences Center

Toronto, Canada

Location

Saint Paul's Hospital

Vancouver, Canada

Location

Angiografia de Occidente S.A.

Cali, Colombia

Location

Nemocnice Podlesi a.s.

Třinec, Czechia

Location

Centre Hospitalier Universitaire - Hopital Henri Mondor

Créteil, France

Location

Centre Hospitalier Regional Universitaire de Lille

Lille, France

Location

Institut Hospitalier Jacques Cartier

Massy, France

Location

Hopital Bichat - Claude Bernard

Paris, France

Location

Clinique Pasteur

Toulouse, France

Location

Herz- und Diabeteszentrum NRW - Ruhr-Universitaet Bochum

Bad Oeynhausen, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, Germany

Location

University of Bonn, Cardiology

Bonn, Germany

Location

Sana-Herzzentrum Cottbus GmbH

Cottbus, Germany

Location

Herzzentrum Dresden GmbH Universitaetsklinik

Dresden, Germany

Location

Universitaetsklinikum Düsseldorf

Düsseldorf, Germany

Location

Elisabeth-Krankenhaus Essen GmbH

Essen, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

University of Frankfurt

Frankfurt, Germany

Location

Asklepios Klinik Sankt Georg

Hamburg, Germany

Location

Städtisches Klinikum Karlsruhe GmbH

Karlsruhe, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, Germany

Location

Deutsches Herzzentrum Muenchen - Klinik an der TU Muenchen

Munich, Germany

Location

Hygeia Hospital

Athens, Greece

Location

Semmelweis Egyetem AOK

Budapest, Hungary

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy

Location

Presidio Ospedaliero Ferrarotto Alessi

Catania, Italy

Location

IRCCS Policlinico San Donato

Milan, Italy

Location

Ospedale San Raffaele - Milano

Milan, Italy

Location

Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

Pisa, Italy

Location

Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark

Amsterdam, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, Netherlands

Location

Oslo Universitetssykehus-Ullevål Universitetssykehus

Oslo, Norway

Location

Complejo Hospitalario Dr Arnulfo Arias Madrid

Panama City, Panama

Location

Instytut Kardiologii

Warsaw, Poland

Location

Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I

Vila Nova de Gaia, Portugal

Location

Prince Sultan Cardiac Center

Riyadh, Saudi Arabia

Location

Mediclinic Panorama

Cape Town, South Africa

Location

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Location

Akademiska Sjukhuset

Uppsala, Sweden

Location

Royal Victoria Hospital - Belfast Health and Social Care Trust

Belfast, United Kingdom

Location

Royal Sussex County Hospital

Brighton, United Kingdom

Location

The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary

Leeds, United Kingdom

Location

The Royal Wolverhampton Hospitals NHS - New Cross Hospital

Wolverhampton, United Kingdom

Location

Related Publications (29)

• Rodes-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Feindel CM, Osten M, Natarajan MK, Velianou JL, Martucci G, DeVarennes B, Chisholm R, Peterson MD, Lichtenstein SV, Nietlispach F, Doyle D, DeLarochelliere R, Teoh K, Chu V, Dancea A, Lachapelle K, Cheema A, Latter D, Horlick E. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol. 2010 Mar 16;55(11):1080-90. doi: 10.1016/j.jacc.2009.12.014. Epub 2010 Jan 22.

  PMID: 20096533 RESULT

• Thomas M, Schymik G, Walther T, Himbert D, Lefevre T, Treede H, Eggebrecht H, Rubino P, Michev I, Lange R, Anderson WN, Wendler O. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010 Jul 6;122(1):62-9. doi: 10.1161/CIRCULATIONAHA.109.907402. Epub 2010 Jun 21.

  PMID: 20566953 RESULT

• Lefevre T, Kappetein AP, Wolner E, Nataf P, Thomas M, Schachinger V, De Bruyne B, Eltchaninoff H, Thielmann M, Himbert D, Romano M, Serruys P, Wimmer-Greinecker G; PARTNER EU Investigator Group. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur Heart J. 2011 Jan;32(2):148-57. doi: 10.1093/eurheartj/ehq427. Epub 2010 Nov 12.

  PMID: 21075775 RESULT

• Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

  PMID: 20961243 RESULT

• Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.

  PMID: 21639811 RESULT

• Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Kafi A, Schreiber T, Gleason TG, Conte J, Buchbinder M, Deeb GM, Carabello B, Serruys PW, Chenoweth S, Oh JK; CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014 May 20;63(19):1972-81. doi: 10.1016/j.jacc.2014.02.556. Epub 2014 Mar 19.

  PMID: 24657695 RESULT

• Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.

  PMID: 24678937 RESULT

• Webb JG, Wood DA. Current status of transcatheter aortic valve replacement. J Am Coll Cardiol. 2012 Aug 7;60(6):483-92. doi: 10.1016/j.jacc.2012.01.071. Epub 2012 Jun 27.

  PMID: 22749306 RESULT

• Genereux P, Head SJ, Wood DA, Kodali SK, Williams MR, Paradis JM, Spaziano M, Kappetein AP, Webb JG, Cribier A, Leon MB. Transcatheter aortic valve implantation 10-year anniversary: review of current evidence and clinical implications. Eur Heart J. 2012 Oct;33(19):2388-98. doi: 10.1093/eurheartj/ehs220. Epub 2012 Jul 31.

  PMID: 22851654 RESULT

• Buellesfeld L, Gerckens U, Schuler G, Bonan R, Kovac J, Serruys PW, Labinaz M, den Heijer P, Mullen M, Tymchak W, Windecker S, Mueller R, Grube E. 2-year follow-up of patients undergoing transcatheter aortic valve implantation using a self-expanding valve prosthesis. J Am Coll Cardiol. 2011 Apr 19;57(16):1650-7. doi: 10.1016/j.jacc.2010.11.044.

  PMID: 21492762 RESULT

• Ussia GP, Barbanti M, Petronio AS, Tarantini G, Ettori F, Colombo A, Violini R, Ramondo A, Santoro G, Klugmann S, Bedogni F, Maisano F, Marzocchi A, Poli A, De Carlo M, Napodano M, Fiorina C, De Marco F, Antoniucci D, de Cillis E, Capodanno D, Tamburino C; CoreValve Italian Registry Investigators. Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis. Eur Heart J. 2012 Apr;33(8):969-76. doi: 10.1093/eurheartj/ehr491. Epub 2012 Jan 12.

  PMID: 22240494 RESULT

• Walther T, Dewey T, Borger MA, Kempfert J, Linke A, Becht R, Falk V, Schuler G, Mohr FW, Mack M. Transapical aortic valve implantation: step by step. Ann Thorac Surg. 2009 Jan;87(1):276-83. doi: 10.1016/j.athoracsur.2008.08.017.

  PMID: 19101311 RESULT

• Walther T, Mollmann H, van Linden A, Kempfert J. Transcatheter aortic valve implantation transapical: step by step. Semin Thorac Cardiovasc Surg. 2011 Spring;23(1):55-61. doi: 10.1053/j.semtcvs.2011.05.006.

  PMID: 21807300 RESULT

• Lange R, Bleiziffer S, Piazza N, Mazzitelli D, Hutter A, Tassani-Prell P, Laborde JC, Bauernschmitt R. Incidence and treatment of procedural cardiovascular complications associated with trans-arterial and trans-apical interventional aortic valve implantation in 412 consecutive patients. Eur J Cardiothorac Surg. 2011 Nov;40(5):1105-13. doi: 10.1016/j.ejcts.2011.03.022. Epub 2011 Apr 22.

  PMID: 21515069 RESULT

• Miller DC, Blackstone EH, Mack MJ, Svensson LG, Kodali SK, Kapadia S, Rajeswaran J, Anderson WN, Moses JW, Tuzcu EM, Webb JG, Leon MB, Smith CR; PARTNER Trial Investigators and Patients; PARTNER Stroke Substudy Writing Group and Executive Committee. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg. 2012 Apr;143(4):832-843.e13. doi: 10.1016/j.jtcvs.2012.01.055.

  PMID: 22424519 RESULT

• Eggebrecht H, Schmermund A, Voigtlander T, Kahlert P, Erbel R, Mehta RH. Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients. EuroIntervention. 2012 May 15;8(1):129-38. doi: 10.4244/EIJV8I1A20.

  PMID: 22391581 RESULT

• Nuis RJ, Van Mieghem NM, Schultz CJ, Moelker A, van der Boon RM, van Geuns RJ, van der Lugt A, Serruys PW, Rodes-Cabau J, van Domburg RT, Koudstaal PJ, de Jaegere PP. Frequency and causes of stroke during or after transcatheter aortic valve implantation. Am J Cardiol. 2012 Jun 1;109(11):1637-43. doi: 10.1016/j.amjcard.2012.01.389. Epub 2012 Mar 15.

  PMID: 22424581 RESULT

• Sinning JM, Hammerstingl C, Vasa-Nicotera M, Adenauer V, Lema Cachiguango SJ, Scheer AC, Hausen S, Sedaghat A, Ghanem A, Muller C, Grube E, Nickenig G, Werner N. Aortic regurgitation index defines severity of peri-prosthetic regurgitation and predicts outcome in patients after transcatheter aortic valve implantation. J Am Coll Cardiol. 2012 Mar 27;59(13):1134-41. doi: 10.1016/j.jacc.2011.11.048.

  PMID: 22440213 RESULT

• Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26.

  PMID: 22443479 RESULT

• Tchetche D, Dumonteil N, Sauguet A, Descoutures F, Luz A, Garcia O, Soula P, Gabiache Y, Fournial G, Marcheix B, Carrie D, Fajadet J. Thirty-day outcome and vascular complications after transarterial aortic valve implantation using both Edwards Sapien and Medtronic CoreValve bioprostheses in a mixed population. EuroIntervention. 2010 Jan;5(6):659-65. doi: 10.4244/eijv5i6a109.

  PMID: 20142215 RESULT

• Van Mieghem NM, Nuis RJ, Piazza N, Apostolos T, Ligthart J, Schultz C, de Jaegere PP, Serruys PW. Vascular complications with transcatheter aortic valve implantation using the 18 Fr Medtronic CoreValve System: the Rotterdam experience. EuroIntervention. 2010 Jan;5(6):673-9. doi: 10.4244/eijv5i6a111.

  PMID: 20142217 RESULT

• Piazza N, Nuis RJ, Tzikas A, Otten A, Onuma Y, Garcia-Garcia 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 implantation. EuroIntervention. 2010 Sep;6(4):475-84. doi: 10.4244/EIJ30V6I4A80.

  PMID: 20884435 RESULT

• Fraccaro C, Buja G, Tarantini G, Gasparetto V, Leoni L, Razzolini R, Corrado D, Bonato R, Basso C, Thiene G, Gerosa G, Isabella G, Iliceto S, Napodano M. Incidence, predictors, and outcome of conduction disorders after transcatheter self-expandable aortic valve implantation. Am J Cardiol. 2011 Mar 1;107(5):747-54. doi: 10.1016/j.amjcard.2010.10.054. Epub 2011 Jan 19.

  PMID: 21247519 RESULT

• van der Boon RM, Nuis RJ, Van Mieghem NM, Jordaens L, Rodes-Cabau J, van Domburg RT, Serruys PW, Anderson RH, de Jaegere PP. New conduction abnormalities after TAVI--frequency and causes. Nat Rev Cardiol. 2012 May 1;9(8):454-63. doi: 10.1038/nrcardio.2012.58.

  PMID: 22547171 RESULT

• Tzikas A, van Dalen BM, Van Mieghem NM, Gutierrez-Chico JL, Nuis RJ, Kauer F, Schultz C, Serruys PW, de Jaegere PP, Geleijnse ML. Frequency of conduction abnormalities after transcatheter aortic valve implantation with the Medtronic-CoreValve and the effect on left ventricular ejection fraction. Am J Cardiol. 2011 Jan 15;107(2):285-9. doi: 10.1016/j.amjcard.2010.09.015. Epub 2010 Dec 2.

  PMID: 21129715 RESULT

• Sherif MA, Abdel-Wahab M, Stocker B, Geist V, Richardt D, Tolg R, Richardt G. Anatomic and procedural predictors of paravalvular aortic regurgitation after implantation of the Medtronic CoreValve bioprosthesis. J Am Coll Cardiol. 2010 Nov 9;56(20):1623-9. doi: 10.1016/j.jacc.2010.06.035.

  PMID: 21050971 RESULT

• Takagi K, Latib A, Al-Lamee R, Mussardo M, Montorfano M, Maisano F, Godino C, Chieffo A, Alfieri O, Colombo A. Predictors of moderate-to-severe paravalvular aortic regurgitation immediately after CoreValve implantation and the impact of postdilatation. Catheter Cardiovasc Interv. 2011 Sep 1;78(3):432-43. doi: 10.1002/ccd.23003. Epub 2011 Jul 25.

  PMID: 21793168 RESULT

• Manoharan G, Van Mieghem NM, Windecker S, Bosmans J, Bleiziffer S, Modine T, Linke A, Scholtz W, Chevalier B, Gooley R, Zeng C, Oh JK, Grube E. 1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve: From the International FORWARD Study. JACC Cardiovasc Interv. 2018 Nov 26;11(22):2326-2334. doi: 10.1016/j.jcin.2018.07.032.

  PMID: 30466832 DERIVED

• Grube E, Van Mieghem NM, Bleiziffer S, Modine T, Bosmans J, Manoharan G, Linke A, Scholtz W, Tchetche D, Finkelstein A, Trillo R, Fiorina C, Walton A, Malkin CJ, Oh JK, Qiao H, Windecker S; FORWARD Study Investigators. Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study. J Am Coll Cardiol. 2017 Aug 15;70(7):845-853. doi: 10.1016/j.jacc.2017.06.045.

  PMID: 28797353 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Eberhard Grube, Prof. Dr.

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

• Stephan Windecker, Prof. Dr.

  INSELSPITAL, Universitätsspital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 30, 2015
• Study Start: January 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 6, 2020
• Last Updated: April 30, 2020

Record last verified: 2020-04

Locations

NL (4); GR (1); FR (5); NO (1); PT (1); SE (1); SA (1); DE (13); BE (1); PA (1); IL (1); PL (1); ES (3); GB (4); CO (1); CA (3); HU (1); CZ (1); AU (4); ZA (1); IT (5)