Brief Title
The Medtronic TAVR 2.0 US Clinical Study
Official Title
The Medtronic TAVR 2.0 US Clinical Study
Brief Summary
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
Detailed Description
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.
Study Type
Interventional
Primary Outcome
All-cause Mortality Rate
Secondary Outcome
Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components:
Condition
Aortic Valve Stenosis
Intervention
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
Study Arms / Comparison Groups
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
Description: Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
60
Start Date
April 2016
Completion Date
November 2021
Primary Completion Date
November 2016
Eligibility Criteria
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)
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
John Forrest, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02738853
Organization ID
10233065DOC
Responsible Party
Sponsor
Study Sponsor
Medtronic Cardiovascular
Study Sponsor
John Forrest, MD, Principal Investigator, Yale New Haven Hospital
Verification Date
April 2020