Clinical trial NCT01240902: Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
Official title: Medtronic CoreValve® U.S. Pivotal Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Aortic Stenosis
Keywords: Valvular Heart Disease
Critical Aortic Stenosis
Severe Aortic Stenosis
High Risk
Aortic Valve Replacement
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2010-11-15
Enrollment: 1453
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 high risk for aortic valve surgery and/or very high risk for aortic valve surgery.


Eligibility criteria: Inclusion Criteria:

* Extreme Risk Only: Subject must have comorbidities 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.
* High Risk Surgical Only: Subject must have comorbidities 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.
* 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.

Exclusion Criteria:

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 intended treatment. (High Risk Surgical Only: Including bare metal stents. Additionally, any drug eluting stents placed within 6 months prior to the index 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).
* End stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min.
* Active Gastrointestinal (GI) bleeding within the past 3 months.
* A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
* Aspirin
* Heparin (HIT/HITTS)
* Bivalirudin (Extreme Risk Only)
* Nitinol (titanium or nickel)
* Ticlopidine and clopidogrel
* Contrast media
* 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 trial/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 trial.
* Symptomatic carotid or vertebral artery disease.
* Subject has been offered surgical aortic valve replacement but declined. (High Risk Surgical Only)

Anatomical

* Native aortic annulus size \< 18 mm or \> 29 mm per the baseline diagnostic imaging.
* Pre-existing prosthetic heart valve any position.
* Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation (3-4+)).
* Moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation.
* Moderate to severe mitral stenosis.
* Hypertrophic obstructive cardiomyopathy.
* New or untreated echocardiographic evidence of 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 diameter \> 43 mm if the aortic annulus diameter is 23-29 mm; ascending aorta diameter \> 40 mm if the aortic annulus diameter is 20-23 mm; or an ascending aorta diameter \> 34 mm if the aortic annulus diameter is 18-20 mm.
* Congenital bicuspid or unicuspid valve verified by echocardiography.
* Sinus of valsalva anatomy that would prevent adequate coronary perfusion.

Vascular

- Transarterial access not able to accommodate an 18Fr sheath.

Primary outcomes:
measure: Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality
timeFrame: 1 year
Secondary outcomes:
measure: Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
timeFrame: 30 day, 6 month, 1 year, 2 year
measure: The Occurrence of Individual MACCE Components
timeFrame: 30 day, 6 month, 1 year, 2 year
measure: Major Adverse Events (MAEs)
timeFrame: 30 day, 6 month, 1 year, 2 year
measure: Conduction Disturbance Requiring Permanent Pacemaker Implantation
timeFrame: 30 day, 6 month, 1 year, 2 year
measure: Change in NYHA Class
timeFrame: 30 day, 6 month, 1 year, 2 year
measure: Change in Distance Walked During 6-Minute Walk Test (6MWT)
timeFrame: 30 day, 1 year
measure: Ratio of Days Alive Out of Hospital Versus Total Days Alive
timeFrame: 1 year
measure: Quality of Life (QoL) Change
timeFrame: 30 day, 6 month, 1 year, 2 year
measure: Echocardiographic Assessment of Valve Performance
timeFrame: 30 day, 6 month, 1 year, 2 year
measure: Echocardiographic Assessment of Valve Performance
timeFrame: 30 day, 6 month, 1 year, 2 year
measure: Echocardiographic Assessment of Valve Performance
timeFrame: 30 day, 6 month, 1 year, 2 year
measure: Aortic Valve Hospitalizations
timeFrame: 30 day, 6 month, 1 year, 2 year
measure: Cardiovascular Deaths and Valve Related Deaths
timeFrame: 30 day, 6 month, 1 year, 2 year
measure: Strokes and Transient Ischemic Attacks (TIAs)
timeFrame: 30 day, 6 month, 1 year, 2 year
measure: Index Procedure Related MAEs
timeFrame: Procedure
measure: Length of Index Procedure Hospital Stay
timeFrame: Number of days from admission to discharge
measure: Device Success
timeFrame: Number of days from admission to discharge
measure: Procedural Success
timeFrame: Number of days from admission to discharge
measure: Prosthetic Valve Dysfunction (PVD)
timeFrame: 30 day, 6 month, 1 year, 2 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Good Samaritan
state: Arizona
city: Los Angeles
country: United States
facility: Kaiser Permanente - Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California University Hospital
state: California
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center / Georgetown Hospital
state: District of Columbia
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: University of Miami Health System / Jackson Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Atlanta
country: United States
facility: Saint Joseph's Hospital of Atlanta
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Houma
country: United States
facility: Cardiovascular Institute of the South/ Terrebone General
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
city: Detroit
country: United States
facility: Detroit Medical Center Cardiovascular Institute
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Manhasset
country: United States
facility: North Shore University Hospital/ Long Island Jewish Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: The Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University - Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals - Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center - The Richard M. Ross Heart Hospital
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute at St. Luke's Episcopal Hospital
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital - The Methodist DeBakey Heart & Vascular Center
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center
state: Washington
city: Milwaukee
country: United States
facility: St. Luke's Medical Center - Aurora Health Care
state: Wisconsin
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: David H Adams, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Crestanello JA, Popma JJ, Adams DH, Deeb GM, Mumtaz M, George B, Huang J, Reardon MJ. Long-Term Health Benefit of Transcatheter Aortic Valve Replacement in Patients With Chronic Lung Disease. JACC Cardiovasc Interv. 2017 Nov 27;10(22):2283-2293. doi: 10.1016/j.jcin.2017.07.025. Epub 2017 Nov 1.
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citation: Hermiller JB Jr, Yakubov SJ, Reardon MJ, Deeb GM, Adams DH, Afilalo J, Huang J, Popma JJ; CoreValve United States Clinical Investigators. Predicting Early and Late Mortality After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2016 Jul 26;68(4):343-52. doi: 10.1016/j.jacc.2016.04.057.
citation: Popma JJ, Gleason TG, Yakubov SJ, Harrison JK, Forrest JK, Maini B, Ruiz CE, Pinto DS, Costa M, Resar J, Conte J, Crestanello J, Chang Y, Oh JK, Reardon MJ, Adams DH. Relationship of Annular Sizing Using Multidetector Computed Tomographic Imaging and Clinical Outcomes After Self-Expanding CoreValve Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2016 Jul;9(7):e003282. doi: 10.1161/CIRCINTERVENTIONS.115.003282.
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