Overview

This trial is active, not recruiting.

Condition severe aortic stenosis
Treatment medtronic corevalve® system transcatheter aortic valve implantation (tavi)
Sponsor Medtronic Cardiovascular
Start date August 2012
End date August 2017
Trial size 782 participants
Trial identifier NCT01675440, 10050361DOC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Mitral valve regurgitation ≥3-4+
medtronic corevalve® system transcatheter aortic valve implantation (tavi)
Tricuspid valve regurgitation ≥3-4+
medtronic corevalve® system transcatheter aortic valve implantation (tavi)
End stage renal disease requiring renal replacement therapy or a creatinine clearance (CRCL) <20 cc/min, but not on dialysis
medtronic corevalve® system transcatheter aortic valve implantation (tavi)
Low gradient low output aortic stenosis
medtronic corevalve® system transcatheter aortic valve implantation (tavi)
Stenosed, insufficient or combined bioprosthetic surgical aortic valve failure
medtronic corevalve® system transcatheter aortic valve implantation (tavi)
2 or more of the listed conditions
medtronic corevalve® system transcatheter aortic valve implantation (tavi)

Primary Outcomes

Measure
All-cause Mortality or Major stroke
time frame: 12 months

Secondary Outcomes

Measure
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) Event Rate
time frame: 30 days, 6 months, 12 months and annually thereafter up to 5 years
The Occurrence of individual MACCE Components
time frame: 30 days, 6 months, 12 months and annually thereafter up to 5 years
Major Adverse Events (MAEs)
time frame: 30 days, 6 months, 12 months and annually thereafter up to 5 years
Conduction Disturbance Requiring Permanent Pacemaker Implantation
time frame: 30 days, 6 months, 12 months and annually thereafter up to 5 years
Change in NYHA Class
time frame: 30 days, 6 months, 12 months and annually thereafter up to 5 years
Change in Distance Walked During 6-minute Walk Test (6MWT) from Baseline
time frame: 30 days and 12 months
Ratio of Days Alive Out of Hospital Versus Total Days Alive
time frame: 12 months
Quality of Life (QoL) Change from Baseline
time frame: 30 days, 6 months, 12 months and annually thereafter up to 5 years
Echocardiographic Assessment of Valve Performance
time frame: 30 days, 6 months, 12 months and annually thereafter up to 5 years
Aortic Valve Disease Hospitalization
time frame: 30 days, 6 months, 12 months and annually thereafter up to 5 years
Cardiovascular Deaths and Valve-related Deaths
time frame: 30 days, 6 months, 12 months and annually thereafter up to 5 years
Strokes
time frame: 30 days, 6 months, 12 months and annually thereafter up to 5 years
Index Procedure Related Major Adverse Events (MAEs)
time frame: Procedure
Length of Index Procedure Hospital Stay
time frame: Number of days from admission to discharge
Device Success
time frame: Number of days from admission to discharge
Procedural Success
time frame: Number of days from admission to discharge
Evidence of Prosthetic Valve Dysfunction
time frame: 30 days, 6 months, 12 months and annually thereafter up to 5 years

Eligibility Criteria

Male or female participants of any age.

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 <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.

Additional Information

Official title Medtronic CoreValve® U.S. Expanded Use Study
Description The primary objective of the study is to evaluate the safety and effectiveness of the Medtronic CoreValve® System (MCS) in a subset of subjects excluded from the U.S. Extreme Risk Pivotal Trial population due to one or more additional co-morbidities, as measured by a composite of all-cause death or major stroke at 12 months, in the treatment of symptomatic severe aortic stenosis in subjects necessitating aortic valve replacement. Subjects enrolled in this study have a predicted operative mortality or serious, irreversible morbidity risk of ≥50% at 30 days associated with surgical aortic valve replacement.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Medtronic Cardiovascular.