The Medtronic TAVR 2.0 US Clinical Study

Medtronic Cardiovascular8 sites in 1 country93 target enrollmentApril 2016

ConditionsAortic Valve Stenosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Medtronic Cardiovascular
Enrollment: 93
Locations: 8
Primary Endpoint: All-cause Mortality Rate
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2016

End Date

December 15, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Cardiovascular

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

All-cause Mortality Rate

Time Frame: 30 days

Stroke (Disabling) Rate

Time Frame: 30 days

The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram

Time Frame: 30 days

Secondary Outcomes

Hemodynamic Performance - Aortic Valve Area(30 days)
Percentage of Participants With Coronary Artery Obstruction(30 days)
Percentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure(30 days)
Device Success Rate (VARC II)(24 hours to 7 days)
Percentage of Participants With Life Threatening or Disabling Bleeding(30 days)
Percentage of Participants With Major Vascular Complication(30 days)
Hemodynamic Performance - Mean Gradient(30 days)
Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components:(30 days)
Percentage of Patient With Acute Kidney Injury- Stage 2 or 3(30 days)
Hemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace(30 days)