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INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc. 2013. All.

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Presentation on theme: "INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc. 2013. All."— Presentation transcript:

1 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. UC b EE1P Medtronic CoreValve ® US Pivotal Trial

2 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. CoreValve ® US Pivotal Trial Study Design 1-3 Extreme RiskHigh Risk CoreValve Observational CoreValve Single Arm CoreValveSAVR Iliofemoral Access?Randomization 1:1 No Medtronic CoreValve US Pivotal Trial 45 Sites Estimated Enrollment: ~1,575 Yes a Includes patients with iliofemoral and alternative access. SAVR=surgical aortic valve replacement. 1. Medtronic CoreValve ® U.S. Pivotal Trial. US National Institutes of Health Web site. Accessed 12/2/ Medtronic CoreValve ® U.S. Pivotal Trial (Extreme Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; Medtronic CoreValve ® U.S. Pivotal Trial (High Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; Alternative Access

3 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. CoreValve ® US Pivotal Trial Overview 1-3 Randomized, open-label study The trial was conducted at 45 investigational sites in the United States Number of trial subjects – –Sample size Extreme Risk Cohort – –~500 Medtronic CoreValve System TAVI received 26, 29 or 31mm valve – –Up to 20 subjects receiving 23mm valve (either ilio-femoral or non-ilio- femoral) – –~200 non-ilio-femoral observational arm for 26, 29, and 31mm valves (direct aortic/subclavian) High Risk Surgical Cohort – –~395 Medtronic CoreValve System TAVI – –~395 surgical aortic valve replacement Includes non-ilio-femoral access (direct aortic/subclavian) – –Up to 40 additional subjects (20 receiving TAVI and 23mm valve) TAVI=transcatheter aortic valve implantation. 1. Medtronic CoreValve ® U.S. Pivotal Trial. US National Institutes of Health Web site. Accessed 12/2/ Medtronic CoreValve ® U.S. Pivotal Trial (Extreme Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; Medtronic CoreValve ® U.S. Pivotal Trial (High Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; 2012.

4 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. CoreValve ® US Pivotal Trial Patient Populations Extreme Risk Cohort 1 Subjects with symptomatic severe aortic stenosis, necessitating aortic valve replacement, with predicted operative mortality or serious, irreversible morbidity risk of ≥50% at 30 days High Risk Surgical Cohort 2 Subjects with symptomatic severe aortic stenosis, necessitating aortic valve replacement, whose predicted risk of operative mortality is ≥15% (and whose predicted operative mortality or serious, irreversible morbidity risk is <50%) at 30 days 1. Medtronic CoreValve ® U.S. Pivotal Trial (Extreme Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; Medtronic CoreValve ® U.S. Pivotal Trial (High Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; 2012.

5 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. CoreValve ® US Pivotal Trial Primary Objective and Endpoint Extreme Risk Cohort Primary objective – –Demonstrate the safety and effectiveness of the Medtronic CoreValve System, as measured by a composite of all-cause death or major stroke at 12 months, in subjects necessitating aortic valve replacement with predicted operative mortality or serious, irreversible morbidity risk of ≥50% at 30 days Primary endpoint – –All-cause death or major stroke at 12 months (compared to performance goal) Medtronic CoreValve ® U.S. Pivotal Trial (Extreme Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; 2012.

6 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. CoreValve ® US Pivotal Trial Primary Objective and Endpoint (Cont.) High Risk Surgical Cohort Primary objective – –Demonstrate that the safety and effectiveness of the Medtronic CoreValve System, as measured by all-cause mortality rates at 12 months, is noninferior to surgical aortic valve replacement in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery Primary endpoint – –All-cause mortality at 12 months Medtronic CoreValve ® U.S. Pivotal Trial (High Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; 2012.

7 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. CoreValve ® US Pivotal Trial Secondary Safety Outcomes 1,2 MACCE-free survival at 30 days, 6 months, 12 months, and annually thereafter up to 5 years – –MACCE is defined as a composite of all-cause death, myocardial infarction, all stroke, and reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve) Occurrence of individual MACCE components at 30 days, 6 months, 12 months, and annually thereafter up to 5 years Conduction disturbance requiring permanent pacemaker implantation at 30 days, 6 months, 12 months, and annually thereafter up to 5 years Echocardiographic assessment of prosthetic valve performance at discharge, 30 days, 6 months, 12 months, and annually thereafter up to 5 years MACCE=major adverse cardiovascular and cerebrovascular event. 1. Medtronic CoreValve ® U.S. Pivotal Trial (Extreme Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; Medtronic CoreValve ® U.S. Pivotal Trial (High Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; 2012.

8 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. CoreValve ® US Pivotal Trial Secondary Safety Outcomes 1,2 (Cont.) Major adverse events (MAEs) at 30 days, 6 months, 12 months, and annually thereafter up to 5 years Cardiovascular deaths and valve-related deaths at 30 days, 6 months, 12 months, and annually thereafter up to 5 years Strokes (of any severity) and transitory ischemic attacks at 30 days, 6 months, 12 months, and annually through 5 years Index procedure–related MAEs Evidence of prosthetic valve dysfunction at 30 days, 6 months,12 months, and annually thereafter up to 5 years 1. Medtronic CoreValve ® U.S. Pivotal Trial (Extreme Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; Medtronic CoreValve ® U.S. Pivotal Trial (High Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; 2012.

9 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. CoreValve ® US Pivotal Trial Secondary Safety Outcomes 1,2 (Cont.) Device success defined as follows: – –Successful vascular access, delivery, and deployment of the device, and successful retrieval of the delivery system – –Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function) – –Intended performance of the prosthetic valve (aortic valve area >1.2 cm 2 for 26, 29 and 31mm valves, > 0.9 cm 2 for 23mm valve [by echocardiography using the continuity equation] and mean aortic valve gradient <20 mm Hg or peak velocity <3 m/sec, without moderate or severe prosthetic valve AR) Assessed acutely in a resting state, either within hours after the index procedure or before hospital discharge – –Only 1 valve implanted in the proper anatomical location AR=aortic regurgitation. 1. Medtronic CoreValve ® U.S. Pivotal Trial (Extreme Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; Medtronic CoreValve ® U.S. Pivotal Trial (High Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; 2012.

10 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. CoreValve ® US Pivotal Trial Secondary Effectiveness Outcomes 1,2 Change in NYHA class from baseline at 30 days, 6 months, 12 months, and annually thereafter through 5 years Change in distance walked during 6-minute walk test from baseline to 30 days and baseline to 12 months Ratio of days alive out of hospital vs total days alive assessed at 12-month follow-up Quality of life (Kansas City Cardiomyopathy Questionnaire, Short Form-12, and EuroQol) change from baseline at 30 days, 6 months, 12 months, and annually thereafter up to 5 years NYHA=New York Heart Association. 1. Medtronic CoreValve ® U.S. Pivotal Trial (Extreme Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; Medtronic CoreValve ® U.S. Pivotal Trial (High Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; 2012.

11 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. CoreValve ® US Pivotal Trial Secondary Effectiveness Outcomes 1,2 (Cont.) Aortic valve disease–related hospitalization at 30 days, 6 months, 12 months, and annually thereafter up to 5 years Length of index procedure hospital stay Procedural success, defined as device success and absence of in-hospital MACCE MACCE=major adverse cardiovascular and cerebrovascular event. 1. Medtronic CoreValve ® U.S. Pivotal Trial (Extreme Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; Medtronic CoreValve ® U.S. Pivotal Trial (High Risk Patients). Version Mounds View, MN: Medtronic, Inc. Clinical Research; 2012.

12 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. David Adams, MD Mount Sinai Medical Center Jeffrey Popma, MD Beth Israel Deaconess Medical Center CoreValve ® US Pivotal Trial Principal Investigators 1. Medtronic CoreValve ® U.S. Pivotal Trial. US National Institutes of Health Web site. Accessed 6/30/11.

13 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Participating Study Sites N=1600 estimated enrollment 45 investigator sites

14 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Banner Good Samaritan Phoenix, AZ Timothy Byrne (IC), Michael Caskey (CS) Baylor Heart and Vascular Hospital Dallas, TX Robert Hebeler (CS), Robert Stoler (IC) Beth Israel Deaconess Medical Center Boston, MA Kamal Khabbaz (CS), Jeffrey Popma (IC) Cardiovascular Institute of the South Houma, LA Peter Fail (IC), Edgar Feinberg (CS) Detroit Medical Center Cardiovascular Institute Detroit, MI Ali Kafi (CS), Theodore Schreiber (IC) Duke University Medical Center Durham, NC J. Kevin Harrison (IC), G. Chad Hughes (CS) El Camino Hospital Mountain View, CA Vincent Gaudiani (CS), James Joye (IC) Fletcher Allen Health Care Burlington, VT Harold Dauerman (IC), Joseph Schmoker (CS) CS=cardiac surgeon; IC=interventional cardiologist. CoreValve ® US Pivotal Trial Clinical Trial Sites and Principal Investigators

15 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Geisinger Medical Center Danville, PA Alfred Casale (CS), Kimberly Skelding (IC) Hartford Hospital Hartford, CT Robert Hagberg (CS), Raymond McKay (IC) Inova Fairfax Hospital/ Inova Heart and Vascular Institute Falls Church, VA Niv Ad (CS), Bryan Raybuck (IC) Iowa Heart Center Des Moines, IA Atul Chawla (IC), David Hockmuth (CS) Johns Hopkins Hospital Baltimore, MD John Conte (CS), Jon Resar (IC) Kaiser Permanente/ Los Angeles Medical Center Los Angeles, CA Vicken Aharonian (IC), Thomas Pfeffer (CS) Lenox Hill Hospital New York, NY Gregory Fontana (CS), Chad Kliger (IC) Loyola University Medical Center Maywood, IL Mamdoh Bakhos (CS), Ferdinand Leya (IC) CS=cardiac surgeon; IC=interventional cardiologist. CoreValve ® US Pivotal Trial Clinical Trial Sites and Principal Investigators

16 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Morristown Memorial Hospital Morristown, NJ John Brown (CS), Robert Kipperman (IC) Mount Sinai Medical Center Miami Beach, FL Nirat Beohar (IC), Joseph Lamelas (CS) North Shore University Hospital Manhasset, NY Alan Hartman (CS), Stanley Katz (IC) NYU/Langone Medical Center New York, NY Aubrey Galloway (CS), James Slater (IC) Piedmont Heart Institute Atlanta, GA James Kauten (CS), Vivek Rajagopal (IC) Pinnacle Health Harrisburg, PA Brijeshwar Maini (IC), Mubashir Mumtaz (CS) Providence Sacred Heart Medical Center Spokane, WA Mike Ring (IC), Leland Siwek (CS) Riverside Methodist Hospital/ Ohio Health Research Institute Columbus, OH Daniel Watson (CS), Steven Yakubov (IC) Saint Joseph’s Hospital of Atlanta Atlanta, GA Louis Heller (IC), Steven Macheers (CS) CoreValve ® US Pivotal Trial Clinical Trial Sites and Principal Investigators (Cont.) CS=cardiac surgeon; IC=interventional cardiologist

17 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Spectrum Health Hospitals Grand Rapids, MI John Heiser (CS), William Merhi (IC) St. Francis Hospital Roslyn, NY George Petrossian (IC), Newell Robinson (CS) St. John Hospital & Medical Center Detroit, MI Sanjay Batra (IC), Thomas Davis (CS) St. Luke's Medical Center/ Aurora Health Care Milwaukee, WI Tanvir Bajwa (IC), Daniel O'Hair (CS) St. Vincent Heart Center of Indiana Indianapolis, IN David Heimansohn (CS), James Hermiller (IC) Texas Heart Institute at St. Luke’s Episcopal Hospital/ Baylor College of Medicine Houston, TX Joseph Coselli (CS), Biswajit Kar (IC) The Methodist DeBakey Heart & Vascular Center, The Methodist Hospital Houston, TX Neal S. Kleiman (IC), Michael Reardon (CS) CoreValve ® US Pivotal Trial Clinical Trial Sites and Principal Investigators (Cont.) CS=cardiac surgeon; IC=interventional cardiologist

18 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. The Mount Sinai Medical Center New York, NY David Adams (CS), Samin Sharma (IC) The Ohio State University Medical Center/The Richard M. Ross Heart Hospital Columbus, OH John Cheatham (IC), Juan Crestanello (CS) University Hospitals/Case Medical Center Cleveland, OH Marco Costa (IC), Alan Markowitz (CS) University of Kansas Hospital Kansas City, KS Peter Tadros (IC), George Zorn (CS) University of Miami Health System Miami, FL Eduardo de Marchena (IC), Tomas Salerno (CS) University of Michigan Health Systems Ann Arbor, MI Stanley J. Chetcuti (IC), G. Michael Deeb (CS) University of Pittsburgh Medical Center Pittsburgh, PA Thomas G. Gleason (CS), Joon Lee (IC) University of Southern California University Hospital Los Angeles, CA Ray Matthews (IC), Vaughn Starnes (CS) CoreValve ® US Pivotal Trial Clinical Trial Sites and Principal Investigators (Cont.) CS=cardiac surgeon; IC=interventional cardiologist

19 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. VA Palo Alto Health Care System Stanford, CA John Giacomini (IC), Robert Robbins (CS) Vanderbilt University Medical Center Nashville, TN John Byrne (CS), David Zhao (IC) Wake Forest University/ Baptist Medical Center Winston-Salem, NC Robert Applegate (IC), Neal Kon (CS) Washington Hospital Center/ Georgetown Hospital Washington, DC Ammar Bafi (CS), Ron Waksman (IC) Yale New Haven Hospital/ Yale University School of Medicine New Haven, CT John Elefteriades (CS), Craig Thompson (IC) CoreValve ® US Pivotal Trial Clinical Trial Sites and Principal Investigators (Cont.) CS=cardiac surgeon; IC=interventional cardiologist

20 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. CoreValve ® US Pivotal Trial Additional Information ClinicalTrials.gov identifier: NCT ?term=CoreValve&rank=4&show_locs=Y#locn Medtronic CoreValve US Pivotal Trial site: CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l. © 2013.


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