The Medtronic TAVR 2.0 US Clinical Study

Completed · Not applicable

Conditions studied: Aortic Valve Stenosis

In brief

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

Key facts

Study ID

NCT02738853

Run by

Medtronic Cardiovascular

People needed

93

Starts

2016-04-01

Expected to finish

2021-12-15

Last updated by the study team

2023-03-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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
• Symptoms of aortic stenosis AND New York Heart Association (NYHA) Functional Class II or greater
• The subject and the treating physician agree that the subject will return for all required post procedure follow-up visits.

You may not qualify if…

• Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve)
• 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
• Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
• Untreated clinically significant coronary artery disease requiring revascularization
• Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% by echocardiography, contrast ventriculography, or radionuclide ventriculography
• End stage renal disease requiring chronic dialysis or creatinine clearance <20 cc/min.
• Ongoing sepsis, including active endocarditis
• Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure
• Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
• Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
• Gastrointestinal (GI) bleeding that would preclude anticoagulation
• Subject refuses a blood transfusion
• 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)
• Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions
• 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
• Currently participating in an investigational drug or another device study (excluding registries)
• Evidence of an acute myocardial infarction ≤30 days before the study procedure
• Need for emergency surgery for any reason
• Liver failure (Child-Pugh class C)
• Subject is pregnant or breast feeding

Where it is running

• Yale-New Haven Hospital — New Haven, Connecticut, United States
• The University of Kansas Hospital — Kansas City, Kansas, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• NYU / Langone Medical Center — New York, New York, United States
• New York-Presbyterian Hospital / Columbia University Medical Center — New York, New York, United States
• OhioHealth Riverside Methodist Hospital — Columbus, Ohio, United States
• Houston Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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