Safety & Efficacy Study of the Medtronic CoreValve® System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement

NCT01675440 | Completed DMC

• 1 other identifier: 10050361DOC
• Study Type: observational
• Target: 782
• Locations: 1 country
• Sites: 43

Brief Summary

To evaluate the safety and efficacy of the Medtronic CoreValve® System for the treatment of symptomatic severe aortic stenosis in subjects with significant comorbidities in whom the risk of surgical aortic valve replacement has a predicted operative mortality or serious, irreversible morbidity risk of ≥50% at 30 days.

Conditions

Severe Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• All-cause Mortality or Major stroke

  All-cause Mortality or Major Stroke

  12 months

Secondary Outcomes (17)

• Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) Event Rate

  30 days, 6 months, 12 months and annually thereafter up to 5 years

• The Occurrence of individual MACCE Components

  30 days, 6 months, 12 months and annually thereafter up to 5 years

• Major Adverse Events (MAEs)

  30 days, 6 months, 12 months and annually thereafter up to 5 years

• Conduction Disturbance Requiring Permanent Pacemaker Implantation

  30 days, 6 months, 12 months and annually thereafter up to 5 years

• Change in NYHA Class

  30 days, 6 months, 12 months and annually thereafter up to 5 years

Study Arms (6)

Severe (≥3-4+) Mitral Valve Regurgitation

Mitral valve regurgitation ≥3-4+

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

Severe (≥3-4+) Tricuspid Valve Regurgitation

Tricuspid valve regurgitation ≥3-4+

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

End Stage Renal Disease (ESRD)

End stage renal disease requiring renal replacement therapy or a creatinine clearance (CRCL) \<20 cc/min, but not on dialysis

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

Low Gradient Low Output Aortic Stenosis

Low gradient low output aortic stenosis

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

Failed Bioprosthetic Surgical Aortic Valve

Stenosed, insufficient or combined bioprosthetic surgical aortic valve failure

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

2 or More Conditions

2 or more of the listed conditions

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

Interventions

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

2 or More Conditions; End Stage Renal Disease (ESRD); Failed Bioprosthetic Surgical Aortic Valve; Low Gradient Low Output Aortic Stenosis; Severe (≥3-4+) Mitral Valve Regurgitation; Severe (≥3-4+) Tricuspid Valve Regurgitation

Eligibility Criteria

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

Study Population

Subjects with symptomatic severe aortic stenosis requiring aortic valve replacement, with predicted operative mortality or serious, irreversible morbidity risk of ≥ 50% at 30 days, and at least one of the following conditions: * Severe (≥3-4+) mitral valve regurgitation * Severe (≥3-4+) tricuspid valve regurgitation * End stage renal disease (ESRD) requiring renal replacement therapy or creatinine clearance \<20cc/min, but not requiring renal replacement therapy * Low gradient, low output aortic stenosis * Failed bioprosthetic surgical aortic valve * 2 or more conditions (listed above)

You may qualify if:

• 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.
• Subjects must meet all of the criteria under at least one of the sub-groups 2a-c:
• a. Senile degenerative aortic valve stenosis and i. At least one of the following co-morbid conditions:
• Severe (≥3-4+) mitral valve regurgitation as measured by echocardiography
• Severe (≥3-4+) tricuspid valve regurgitation as measured by echocardiography
• End-stage renal disease requiring renal replacement therapy (Stage 5 of the KDOQI CKD Classification) or creatinine clearance \<20cc/min but not requiring renal replacement therapy
• AND
• ii. mean gradient \> 40 mmHg or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram (if the LVEF \< 50%), or simultaneous pressure recordings at cardiac catheterization either resting or with dobutamine stress (if the LVEF \< 50%) AND iii. 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
• AND/OR
• b. Low gradient, low output aortic stenosis as defined by the presence of all three of the following i. In the presence of LVEF \<50%, absence of contractile reserve, a mean gradient ≥25mmHg and \<40mmHg AND jet velocity less than 4.0m/sec with dobutamine stress echocardiography or simultaneous pressure recordings at cardiac catheterization OR In the presence of LVEF ≥50%, a mean gradient ≥25mmHg and \<40mmHg AND jet velocity less than 4.0 m/sec, by echocardiography or simultaneous pressure recordings at cardiac catheterization AND ii. 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 AND iii. radiographic evidence of severe aortic valve calcification AND/OR c. Failed bioprosthetic surgical aortic valve
• 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 study, 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 MCS TAVI procedure.
• Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the MCS TAVI procedure
• 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).
• Active Gastrointestinal (GI) bleeding that would preclude anticoagulation.
• A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (including ability to be anticoagulated for the index procedure), nitinol, or \[allergic\] sensitivity to contrast media which cannot be adequately pre-medicated.
• Ongoing sepsis, including active endocarditis.
• Subject refuses a blood transfusion.
• Life expectancy \<12 months due to associated non-cardiac co-morbid conditions.
• Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (43)

Banner Good Samaritan

Phoenix, Arizona, 85006, United States

Location

Kaiser Permanente - Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

University of Southern California University Hospital

Los Angeles, California, 90033, 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, 10029, 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, 46290-1090, 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

The 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

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

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Pinnacle Health

Wormleysburg, Pennsylvania, 17101, 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

St. Luke's Medical Center - Aurora Health Care

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (2)

• 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

• Dauerman HL, Deeb GM, O'Hair DP, Waksman R, Yakubov SJ, Kleiman NS, Chetcuti SJ, Hermiller JB Jr, Bajwa T, Khabbaz K, de Marchena E, Salerno T, Dries-Devlin JL, Li S, Popma JJ, Reardon MJ. Durability and Clinical Outcomes of Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses. Circ Cardiovasc Interv. 2019 Oct;12(10):e008155. doi: 10.1161/CIRCINTERVENTIONS.119.008155. Epub 2019 Oct 14.

  PMID: 31607151 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

• David H Adams

  Mount Sinai Health System

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 30, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: April 8, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

US (43)