New heart valve procedure offers hope for patients too sick for surgery

NCT ID NCT01675440

Disease control Sponsor: Medtronic Cardiovascular Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new way to replace a narrowed heart valve without open-heart surgery. It involved 782 people with severe aortic stenosis who were considered too high-risk for traditional surgery. The procedure, called TAVI, uses a thin tube to place a new valve inside the heart. Researchers tracked how many patients survived or had a major stroke within 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Medtronic CoreValve System (a replacement heart valve delivered through a catheter)
What this could lead to: If successful, this could offer a life-saving, less invasive option for people with severe aortic stenosis who are too frail for open-heart surgery.
What could go wrong: This was a single-arm study without a comparison group, so benefits may be overestimated. Risks include stroke, bleeding, and valve complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

782 people

The number who actually took part.

Start date

Aug 2012

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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)

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. Severe (≥3-4+) mitral valve regurgitation as measured by echocardiography 2. Severe (≥3-4+) tricuspid valve regurgitation as measured by echocardiography 3. 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. Exclusion Criteria: 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. * Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits). * Currently participating in an investigational drug or another device study. * Symptomatic carotid or vertebral artery disease. Anatomical Subject has a: * Native aortic annulus size \<18 mm or \>29 mm per the baseline diagnostic imaging (not applicable for TAV in SAV subjects) OR * Surgical bioprosthetic annulus \<17mm or \>29mm i. Stented SAV per the manufactured labeled inner diameter OR ii. Stentless SAV per the baseline diagnostic imaging * Subject has a pre-existing prosthetic heart valve with a rigid support structure in either the mitral or pulmonic position: 1. that could affect the implantation or function of the study valve OR 2. the implantation of the study valve could affect the function of the pre-existing prosthetic heart valve * Moderate to severe mitral stenosis. * Mixed aortic valve disease: aortic stenosis and aortic regurgitation with predominant aortic regurgitation, (AR is moderate-severe to severe (≥3-4+))(except for failed surgical bioprothesis) * Hypertrophic obstructive cardiomyopathy. * Echocardiographic evidence of new or untreated intracardiac mass, thrombus or vegetation. * Severe basal septal hypertrophy with an outflow gradient. * Aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) \>70° (for femoral and left subclavian/axillary access) and \>30° (for right subclavian/axillary access). * Ascending aorta that exceeds the maximum diameter for any given native or surgical bioprosthetic\* aortic annulus size (see table below) Aortic Annulus Diameter/ Ascending Aorta Diameter, 18 mm\* - 20 mm/ \>34 mm, 20 mm - 23 mm/ \>40 mm, 23 mm - 27 mm/ \>43 mm, 27 mm - 29 mm/ \>43 mm, \* 17mm for surgical bioprosthetic aortic annulus * Congenital bicuspid or unicuspid valve verified by echocardiography (Not applicable for TAV in SAV subjects). * Sinus of valsalva anatomy that would prevent adequate coronary perfusion. * Degenerated surgical bioprothesis presents with a significant concomitant perivalvular leak (between prothesis and native annulus), is not securely fixed in the native annulus, or is not structurally intact (e.g. wireform frame fracture) (ONLY FOR TAV in SAV subjects) * Degenerated surgical bioprothesis presents with a partially detached leaflet that in the aortic position may obstruct a coronary ostium (ONLY FOR TAV in SAV subjects) Vascular * Transarterial access not able to accommodate an 18Fr sheath.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Severe aortic stenosis

Contacts and locations

Locations

Banner Good Samaritan

Phoenix, Arizona, 85006, United States
Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Cardiovascular Institute of the South/Terrebonne General

Houma, Louisiana, 70360, United States
Detroit Medical Center Cardiovascular Institute

Detroit, Michigan, 48201, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
Geisinger Medical Center

Danville, Pennsylvania, 17822, United States
Hartford Hospital

Hartford, Connecticut, 06102, United States
Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States
Iowa Heart Center

Des Moines, Iowa, 50314, United States
Kaiser Permanente - Los Angeles Medical Center

Los Angeles, California, 90027, United States
Lenox Hill Hospital

New York, New York, 10075, United States
Loyola University Medical Center

Maywood, Illinois, 60153, United States
Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States
Mount Sinai Medical Center

Miami Beach, Florida, 10029, United States
NYU Langone Medical Center

New York, New York, 10016, United States
North Shore University Hospital

Manhasset, New York, 11030, United States
Piedmont Heart Institute

Atlanta, Georgia, 30309, United States
Pinnacle Health

Wormleysburg, Pennsylvania, 17101, United States
Riverside Methodist Hospital

Columbus, Ohio, 43214, United States
Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342, United States
Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States
St. Francis Hospital

Roslyn, New York, 11576, United States
St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States
St. Luke's Medical Center - Aurora Health Care

Milwaukee, Wisconsin, 53215, United States
St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46290-1090, United States
Texas Heart Institute at St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States
The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States
The Methodist Hospital - The Methodist DeBakey Heart & Vascular Center

Houston, Texas, 77030, United States
The Mount Sinai Medical Center

New York, New York, 10029, United States
The Ohio State University Medical Center - The Richard M. Ross Heart Hospital

Columbus, Ohio, 43210, United States
University Hospitals - Case Medical Center

Cleveland, Ohio, 44106, United States
University of Kansas Hospital

Kansas City, Kansas, 66160, United States
University of Miami Health System / Jackson Memorial Hospital

Miami, Florida, 33136, United States
University of Michigan Health Systems

Ann Arbor, Michigan, 48109, United States
University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States
University of Southern California University Hospital

Los Angeles, California, 90033, United States
University of Vermont Medical Center

Burlington, Vermont, 05458, United States
VA Palo Alto Health Care System

Palo Alto, California, 94304, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States
Wake Forest University - Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States
Washington Hospital Center / Georgetown Hospital

Washington D.C., District of Columbia, 20010, United States
Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

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