Clinical trial NCT02746809: Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum)
Official title: Medtronic CoreValve Evolut R United States Clinical Study (Evolut 34R Addendum)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2016-04-21
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis who are considered at high or extreme risk for surgical aortic valve replacement.

Detailed description: This objective will be accomplished by a prospective, single arm, historical controlled, multi-site study involving up to 60 implanted subjects at up to 15 study sites in the United States. Procedural and 30 day safety and efficacy results from this study will be compared to appropriate historical control data for the Medtronic CoreValve System. Subjects will be followed up to 5 years following implantation.

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.

   Subjects with low-flow/low gradient severe aortic stenosis can be included, provided low-dose dobutamine or exercise stress echocardiography demonstrates a mean gradient of \> 40 mmHg or a maximal aortic valve velocity of \> 4.0 m/sec, AND aortic valve area of \< 1.0 cm2 (or aortic valve area index of \< 0.6 cm2/m2).
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:
5. Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. subject is indicated for mechanical prosthetic valve).
6. 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
7. Blood dyscrasias as defined: leukopenia (WBC \< 1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
8. Untreated clinically significant coronary artery disease requiring revascularization.
9. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
10. End stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min.
11. Ongoing sepsis, including active endocarditis.
12. Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure.
13. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
14. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
15. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
16. Gastrointestinal (GI) bleeding that would preclude anticoagulation.
17. Subject refuses a blood transfusion.
18. 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).
19. Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions.
20. 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-ups exams.
21. Currently participating in an investigational drug or another device study (excluding registries).
22. Evidence of an acute myocardial infarction ≤ 30 days before the study procedure.
23. Need for emergency surgery for any reason.
24. Liver failure (Child-Pugh class C).
25. Subject is pregnant or breast feeding.

    Anatomical exclusion criteria:
26. Pre-existing prosthetic heart valve in any position.
27. Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation).
28. Severe mitral regurgitation.
29. Severe tricuspid regurgitation.
30. Moderate or severe mitral stenosis.
31. Hypertrophic obstructive cardiomyopathy.
32. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation.
33. Congenital bicuspid or unicuspid valve verified by echocardiography.

    For transfemoral or transaxillary (subclavian) access:
34. Access vessel diameter \< 5.5 mm or \<6.0 mm for patent left internal mammary artery (LIMA)

Primary outcomes:
measure: Percentage of Participants With All-cause Mortality
timeFrame: 30 Days
measure: Percentage of Participants With Stroke (Disabling)
timeFrame: 30 Days
measure: Device Success Rate
timeFrame: 24 hours to 7 days post implantation
measure: The Percentage of Subjects With no More Than Mild Prosthetic Regurgitation at Early Post Procedure Echocardiogram
timeFrame: 24 hours to 7 days post implantation
Secondary outcomes:
measure: Percentage of Participants With VARC II Combined Safety Endpoint Event at 30 Days
timeFrame: 30 days post-implantation
measure: Percentage of Participants With Life Threatening or Disabling Bleeding
timeFrame: 30 days post-implantation
measure: Percentage of Participants With Major Vascular Complication
timeFrame: 30 days
measure: Percentage of Participants With Acute Kidney Injury: Stage 2 or 3
timeFrame: 30 days
measure: Percentage of Participants With Coronary Artery Obstruction
timeFrame: 30 days
measure: Percentage of Subjects With Valve-related Dysfunction Requiring Repeat Procedure
timeFrame: 30 days
measure: Percentage of Subjects With Permanent Pacemaker Implant at 30 Days
timeFrame: 30 days
measure: Percentage of Resheath and Recapture Success
timeFrame: Implant procedure
measure: Hemodynamic Performance Metrics - Mean Gradient
timeFrame: 30 days
measure: Hemodynamic Performance Metrics- Aortic Valve Area
timeFrame: 30 Days
measure: Hemodynamic Performance Metrics - Total Prosthetic Regurgitation Graded as None/Trace
timeFrame: 30 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: New York
country: United States
facility: New York Langone Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Harrisburg
country: United States
facility: Pinnacle Health/Moffitt Heart and Vascular Institute
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Milwaukee
country: United States
facility: Aurora Health Care/St Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: NYU Langone Medical Center
name: Mathew R Williams, MD
role: PRINCIPAL_INVESTIGATOR
References: