New heart valve procedure offers hope for patients too sick for surgery
NCT ID NCT01675440
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.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Banner Good Samaritan
Phoenix, Arizona, 85006, United States
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Baylor Heart and Vascular Hospital
Dallas, Texas, 75226, United States
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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Cardiovascular Institute of the South/Terrebonne General
Houma, Louisiana, 70360, United States
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Detroit Medical Center Cardiovascular Institute
Detroit, Michigan, 48201, United States
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
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Hartford Hospital
Hartford, Connecticut, 06102, United States
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Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
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Iowa Heart Center
Des Moines, Iowa, 50314, United States
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Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California, 90027, United States
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Lenox Hill Hospital
New York, New York, 10075, United States
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Loyola University Medical Center
Maywood, Illinois, 60153, United States
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Morristown Memorial Hospital
Morristown, New Jersey, 07962, United States
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Mount Sinai Medical Center
Miami Beach, Florida, 10029, United States
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NYU Langone Medical Center
New York, New York, 10016, United States
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North Shore University Hospital
Manhasset, New York, 11030, United States
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Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
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Pinnacle Health
Wormleysburg, Pennsylvania, 17101, United States
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Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
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Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342, United States
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Spectrum Health Hospitals
Grand Rapids, Michigan, 49503, United States
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St. Francis Hospital
Roslyn, New York, 11576, United States
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St. John Hospital and Medical Center
Detroit, Michigan, 48236, United States
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St. Luke's Medical Center - Aurora Health Care
Milwaukee, Wisconsin, 53215, United States
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St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290-1090, United States
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Texas Heart Institute at St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
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The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
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The Methodist Hospital - The Methodist DeBakey Heart & Vascular Center
Houston, Texas, 77030, United States
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The Mount Sinai Medical Center
New York, New York, 10029, United States
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The Ohio State University Medical Center - The Richard M. Ross Heart Hospital
Columbus, Ohio, 43210, United States
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University Hospitals - Case Medical Center
Cleveland, Ohio, 44106, United States
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University of Kansas Hospital
Kansas City, Kansas, 66160, United States
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University of Miami Health System / Jackson Memorial Hospital
Miami, Florida, 33136, United States
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University of Michigan Health Systems
Ann Arbor, Michigan, 48109, United States
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
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University of Southern California University Hospital
Los Angeles, California, 90033, United States
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University of Vermont Medical Center
Burlington, Vermont, 05458, United States
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VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
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Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
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Wake Forest University - Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
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Washington Hospital Center / Georgetown Hospital
Washington D.C., District of Columbia, 20010, United States
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Yale New Haven Hospital
New Haven, Connecticut, 06520, United States