The Medtronic TAVR 2.0 US Clinical Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2021-12-15

Brief Summary

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The study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement

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Detailed Description

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Prospective, single arm, multi-site study. Patients will be seen at pre and post procedure, discharge, 30 days, 6 months, 1 year, and annually up to 5 years.

Conditions

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Aortic Valve Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medtronic Transcatheter Aortic Valve 2.0 Replacement System

Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System

Group Type EXPERIMENTAL

Medtronic Transcatheter Aortic Valve 2.0 Replacement System

Intervention Type DEVICE

Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.

Interventions

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Medtronic Transcatheter Aortic Valve 2.0 Replacement System

Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Severe aortic stenosis, defined as aortic valve area of \<1.0 cm2 (or aortic valve area index of \<0.6 cm2/m2) by the continuity equation, AND mean gradient \>40 mmHg OR maximal aortic valve velocity \>4.0 m/sec by resting echocardiogram
2. Society of Thoracic Surgeons(STS) score of ≥8 OR documented heart team agreement of ≥ high risk for aortic valve replacement due to frailty or co-morbidities
3. Symptoms of aortic stenosis AND New York Heart Association (NYHA) Functional Class II or greater
4. The subject and the treating physician agree that the subject will return for all required post procedure follow-up visits.

Exclusion Criteria

1. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve)
2. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre medicated:

* aspirin or heparin (HIT/HITTS) and bivalirudin
* ticlopidine and clopidogrel
* nitinol (titanium or nickel)
* contrast media
3. Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
4. Untreated clinically significant coronary artery disease requiring revascularization
5. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20% by echocardiography, contrast ventriculography, or radionuclide ventriculography
6. End stage renal disease requiring chronic dialysis or creatinine clearance \<20 cc/min.
7. Ongoing sepsis, including active endocarditis
8. Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure
9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment
10. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
11. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
12. Gastrointestinal (GI) bleeding that would preclude anticoagulation
13. Subject refuses a blood transfusion
14. 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)
15. Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions
16. Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams
17. Currently participating in an investigational drug or another device study (excluding registries)
18. Evidence of an acute myocardial infarction ≤30 days before the study procedure
19. Need for emergency surgery for any reason
20. Liver failure (Child-Pugh class C)
21. Subject is pregnant or breast feeding
22. Pre existing prosthetic heart valve in any position
23. Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation)
24. Severe mitral regurgitation
25. Severe tricuspid regurgitation
26. Moderate or severe mitral stenosis
27. Hypertrophic obstructive cardiomyopathy
28. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation
29. Congenital bicuspid or unicuspid valve verified by echocardiography
30. Access vessel diameter \<5.5 mm or \<6.0 mm for patent left internal mammary artery (LIMA)

Eligible Sex

ALL

Accepts Healthy Volunteers

No