Overview

This trial is active, not recruiting.

Condition severe aortic stenosis
Treatment medtronic corevalve® system transcatheter aortic valve implantation (tavi)
Phase phase 3
Sponsor Medtronic Cardiovascular
Start date February 2012
End date November 2015
Trial size 1690 participants
Trial identifier NCT01531374, 10037989DOC REV 1C

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 very high risk and high risk for aortic valve surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
medtronic corevalve® system transcatheter aortic valve implantation (tavi)
(Experimental)
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
medtronic corevalve® system transcatheter aortic valve implantation (tavi)
(Experimental)
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
medtronic corevalve® system transcatheter aortic valve implantation (tavi)

Primary Outcomes

Measure
All-cause Death or Major Stroke
time frame: 12 Months

Secondary Outcomes

Measure
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)-free survival
time frame: 5 years
The occurrence of individual MACCE components
time frame: 5 years
Major Adverse Events (MAE)
time frame: 5 years
Conduction disturbance requiring permanent pacemaker implantation
time frame: 5 years
Change in NYHA class
time frame: 5 years
Change in distance walked during 6-minute walk test (6MWT)
time frame: 12 months
Ratio of days alive out of hospital versus total days alive
time frame: 12 months
Quality of Life (QoL) change
time frame: 5 years
Echocardiographic assessment of valve performance
time frame: 5 years
Aortic valve disease hospitalization
time frame: 5 years
Cardiovascular deaths and valve-related deaths
time frame: 5 years
Strokes (of any severity) and Transient Ischemic Attacks (TIAs)
time frame: 5 years
Index procedure related MAEs
time frame: 30 days
Length of index procedure hospital stay
time frame: Admission to discharge
Device success
time frame: Admission to discharge
Procedural success
time frame: Admission to discharge
Evidence of prosthetic valve dysfunction
time frame: 5 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: 1. High Risk: Subject must have co-morbidities 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. OR Extreme Risk: 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. 2. 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 3. Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater. 4. 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. 5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits. Exclusion Criteria: Clinical 1. Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment. 2. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the MCS TAVI procedure including bare metal and drug eluting stents. 3. Blood dyscrasias as defined: leukopenia (WBC < 1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy. 4. Untreated clinically significant coronary artery disease requiring revascularization. 5. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support. 6. Need for emergency surgery for any reason. 7. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% as measured by resting echocardiogram. 8. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA). 9. End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min. 10. Active GI bleeding that would preclude anticoagulation. 11. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: - Aspirin - Heparin (HIT/HITTS) and bivalirudin - Nitinol (titanium or nickel) - Ticlopidine and clopidogrel - Contrast media 12. Ongoing sepsis, including active endocarditis. 13. Subject refuses a blood transfusion. 14. Life expectancy < 12 months due to associated non-cardiac co-morbid conditions. 15. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent. 16. 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). 17. Currently participating in an investigational drug or another device trial. 18. Symptomatic carotid or vertebral artery disease. Anatomical 19. High Risk:Native aortic annulus size < 20 mm or > 29 mm per the baseline diagnostic imaging (until 23mm valve enrollment completion/closure in the CoreValve® US Pivotal Trial-High Risk Cohort) OR Extreme Risk: Native aortic annulus size < 18 mm or > 29 mm per the baseline diagnostic imaging. (High risk and extreme risk upon 23mm valve enrollment completion/closure in the CoreValve® US Pivotal Trial-High Risk Cohort) 20. Pre-existing prosthetic heart valve any position. 21. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation (3-4+)). 22. Moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation. 23. Moderate to severe mitral stenosis. 24. Hypertrophic obstructive cardiomyopathy. 25. Echocardiographic evidence of new or untreated intracardiac mass, thrombus or vegetation. 26. Severe basal septal hypertrophy with an outflow gradient. 27. 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). 28. Ascending aorta diameter >43 mm if the aortic annulus diameter is 23-29 mm; ascending aortic 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 (Extreme Risk only until 23 mm valve enrollment completion/closure in the CoreValve® US Pivotal Trial-High Risk Cohort). 29. Congenital bicuspid or unicuspid valve verified by echocardiography. 30. Sinus of valsalva anatomy that would prevent adequate coronary perfusion. Vascular 31. Transarterial access not able to accommodate an 18Fr sheath.

Additional Information

Official title Medtronic CoreValve® Continued Access Study
Principal investigator Jeffrey J Popma, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Medtronic Cardiovascular.