Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement

NCT01531374 | Completed Results DMC

• 1 other identifier: 10037989DOC REV 1C
• Study Type: interventional
• Target: 2,777
• Locations: 1 country
• Sites: 45

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted very high risk and high risk for aortic valve surgery.

Conditions

Severe Aortic Stenosis

Keywords

Valvular Heart Disease; Critical Aortic Stenosis; Severe Aortic Stenosis; Extreme Risk; High Risk; Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality

  All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)

  1 year

Secondary Outcomes (19)

• Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)

  30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

• The Occurrence of Individual MACCE Components

  30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

• Major Adverse Events (MAEs)

  30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

• Conduction Disturbance Requiring Permanent Pacemaker Implantation

  30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

• Change From Baseline in NYHA Class

  Baseline to 30 days, baseline to 6 months, baseline to 1 year. The 2-5 year outcome data will be reported once data set is complete.

Study Arms (3)

Extreme Risk: TAVI Iliofemoral

EXPERIMENTAL

Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access

Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Extreme Risk: TAVI Non-Iliofemoral

EXPERIMENTAL

Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access

Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

High Risk: TAVI

EXPERIMENTAL

High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Interventions

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) DEVICE

Extreme Risk: TAVI Iliofemoral; Extreme Risk: TAVI Non-Iliofemoral; High Risk: TAVI

Eligibility Criteria

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

You may qualify if:

• High Risk: Subject must have co-morbidities such that one cardiologist and two cardiac surgeons agree that predicted risk of operative mortality is ≥15% (and predicted operative mortality or serious, irreversible morbidity risk of \< 50%) at 30 days.
• Extreme Risk: Subject must have co-morbidities such that one cardiologist and two cardiac surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement. Specifically, the predicted operative risk of death or serious, irreversible morbidity is ≥ 50% at 30 days.
• Subject has senile degenerative aortic valve stenosis with:
• Mean gradient \> 40 mmHg, or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac catheterization (either resting or dobutamine stress), AND
• An initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤ 0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization
• Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater.
• The subject or the subject's legal representative has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site.
• The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

You may not qualify if:

• Clinical
• Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
• Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the MCS TAVI procedure including bare metal and drug eluting stents.
• Blood dyscrasias as defined: leukopenia (WBC \< 1000mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy.
• Untreated clinically significant coronary artery disease requiring revascularization.
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
• Need for emergency surgery for any reason.
• Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20% as measured by resting echocardiogram.
• Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
• End stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min.
• Active GI bleeding that would preclude anticoagulation.
• A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
• Aspirin
• Heparin (HIT/HITTS) and bivalirudin
• Nitinol (titanium or nickel)

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (45)

Banner Good Samaritan

Phoenix, Arizona, 85006, United States

Location

University of Southern California University Hospital

Los Angeles, California, 90033, United States

Location

Kaiser Permanente - Los Angeles Medical Center

Los Angeles, California, 90072, United States

Location

El Camino Hospital

Mountain View, California, 94040, United States

Location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Washington Hospital Center / Georgetown Hospital

Washington D.C., District of Columbia, 20010, United States

Location

University of Miami Health System / Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46290, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50314, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Cardiovascular Institute of the South/Terrebonne General

Houma, Louisiana, 70360, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Health Systems

Ann Arbor, Michigan, 48109, United States

Location

Detroit Medical Center Cardiovascular Institute

Detroit, Michigan, 48201, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

North Shore University Hospital/ Long Island Jewish Hospital

Manhasset, New York, 11030, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

The Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University - Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

University Hospitals - Case Medical Center

Cleveland, Ohio, 44106, United States

Location

The Ohio State University Medical Center - The Richard M. Ross Heart Hospital

Columbus, Ohio, 43210, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Pinnacle Health

Harrisburg, Pennsylvania, 17043, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

Texas Heart Institute at St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital - The Methodist DeBakey Heart & Vascular Center

Houston, Texas, 77030, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05458, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Providence Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

St. Luke's Medical Center - Aurora Health Care

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (6)

• Yakubov SJ, Van Mieghem NM, Oh JK, Ito S, Grubb KJ, O'Hair D, Forrest JK, Gada H, Mumtaz M, Deeb GM, Tang GHL, Rovin JD, Jain R, Windecker S, Skelding KA, Kleiman NS, Chetcuti SJ, Dedrick A, Boatman SV, Popma JJ, Reardon MJ. Impact of Transcatheter or Surgical Aortic Valve Performance on 5-Year Outcomes in Patients at >/= Intermediate Risk. J Am Coll Cardiol. 2025 Apr 8;85(13):1419-1430. doi: 10.1016/j.jacc.2025.02.009. Epub 2025 Mar 9.

  PMID: 40175015 DERIVED

• Klautz RJM, Rao V, Reardon MJ, Deeb GM, Dagenais F, Moront MG, Little SH, Labrousse L, Patel HJ, Ito S, Li S, Sabik JF 3rd, Oh JK. Examining the typical hemodynamic performance of nearly 3000 modern surgical aortic bioprostheses. Eur J Cardiothorac Surg. 2024 May 3;65(5):ezae122. doi: 10.1093/ejcts/ezae122.

  PMID: 38710669 DERIVED

• O'Hair D, Yakubov SJ, Grubb KJ, Oh JK, Ito S, Deeb GM, Van Mieghem NM, Adams DH, Bajwa T, Kleiman NS, Chetcuti S, Sondergaard L, Gada H, Mumtaz M, Heiser J, Merhi WM, Petrossian G, Robinson N, Tang GHL, Rovin JD, Little SH, Jain R, Verdoliva S, Hanson T, Li S, Popma JJ, Reardon MJ. Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk. JAMA Cardiol. 2023 Feb 1;8(2):111-119. doi: 10.1001/jamacardio.2022.4627.

  PMID: 36515976 DERIVED

• Butala NM, Song Y, Shen C, Cohen DJ, Yeh RW. Effect of intensive versus limited monitoring on clinical trial conduct and outcomes: A randomized trial. Am Heart J. 2022 Jan;243:77-86. doi: 10.1016/j.ahj.2021.09.002. Epub 2021 Sep 14.

  PMID: 34529944 DERIVED

• Pineda AM, Kevin Harrison J, Kleiman NS, Reardon MJ, Conte JV, O'Hair DP, Chetcuti SJ, Huang J, Yakubov SJ, Popma JJ, Beohar N. Clinical impact of baseline chronic kidney disease in patients undergoing transcatheter or surgical aortic valve replacement. Catheter Cardiovasc Interv. 2019 Mar 1;93(4):740-748. doi: 10.1002/ccd.27928. Epub 2018 Oct 20.

  PMID: 30341970 DERIVED

• Kleiman NS, Maini BJ, Reardon MJ, Conte J, Katz S, Rajagopal V, Kauten J, Hartman A, McKay R, Hagberg R, Huang J, Popma J; CoreValve Investigators. Neurological Events Following Transcatheter Aortic Valve Replacement and Their Predictors: A Report From the CoreValve Trials. Circ Cardiovasc Interv. 2016 Sep;9(9):e003551. doi: 10.1161/CIRCINTERVENTIONS.115.003551.

  PMID: 27601429 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Hatice Bilgic Lim
• Organization: Medtronic, Inc.

rs.medtroniccardiovascularclinicaltrials@medtronic.com

Study Officials

• David H Adams, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 10, 2012
• Study Start: February 21, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 18, 2019
• Last Updated: October 25, 2022
• Results First Posted: July 18, 2017

Record last verified: 2022-10

Locations

US (45)