Clinical trial NCT02738853: The Medtronic TAVR 2.0 US Clinical Study
Official title: The Medtronic TAVR 2.0 US Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2016-04-14
Enrollment: 93
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 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.

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)

Primary outcomes:
measure: All-cause Mortality Rate
timeFrame: 30 days
measure: Stroke (Disabling) Rate
timeFrame: 30 days
measure: The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram
timeFrame: 30 days
Secondary outcomes:
measure: Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components:
timeFrame: 30 days
measure: Percentage of Participants With Life Threatening or Disabling Bleeding
timeFrame: 30 days
measure: Percentage of Participants With Major Vascular Complication
timeFrame: 30 days
measure: Percentage of Participants With Coronary Artery Obstruction
timeFrame: 30 days
measure: Percentage of Patient With Acute Kidney Injury- Stage 2 or 3
timeFrame: 30 days
measure: Percentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure
timeFrame: 30 days
measure: Device Success Rate (VARC II)
timeFrame: 24 hours to 7 days
measure: Hemodynamic Performance - Aortic Valve Area
timeFrame: 30 days
measure: Hemodynamic Performance - Mean Gradient
timeFrame: 30 days
measure: Hemodynamic Performance - 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: Kansas City
country: United States
facility: The University of Kansas Hospital
state: Kansas
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: New York
country: United States
facility: NYU / Langone Medical Center
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital / Columbia University Medical Center
state: New York
city: Columbus
country: United States
facility: OhioHealth Riverside Methodist Hospital
state: Ohio
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: Yale New Haven Hospital
name: John Forrest, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Medical Center
name: Mathew Williams, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wyler von Ballmoos MC, Reardon MJ, Williams MR, Mangi AA, Kleiman NS, Yakubov SJ, Watson D, Kodali S, George I, Tadros P, Zorn GL 3rd, Brown J, Kipperman R, Oh JK, Qiao H, Forrest JK. Three-Year Outcomes With a Contemporary Self-Expanding Transcatheter Valve From the Evolut PRO US Clinical Study. Cardiovasc Revasc Med. 2021 May;26:12-16. doi: 10.1016/j.carrev.2020.11.007. Epub 2020 Nov 10.
citation: Forrest JK, Mangi AA, Popma JJ, Khabbaz K, Reardon MJ, Kleiman NS, Yakubov SJ, Watson D, Kodali S, George I, Tadros P, Zorn GL 3rd, Brown J, Kipperman R, Saul S, Qiao H, Oh JK, Williams MR. Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap. JACC Cardiovasc Interv. 2018 Jan 22;11(2):160-168. doi: 10.1016/j.jcin.2017.10.014.