The Medtronic TAVR 2.0 US Clinical Study

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

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Medtronic Transcatheter Aortic Valve 2.0 Replacement System

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
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale-New Haven Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Memorial Hospital
  • New York
    • New York, New York, United States, 10016
      • NYU / Langone Medical Center
    • New York, New York, United States, 10032
      • New York-Presbyterian Hospital / Columbia University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43214
      • OhioHealth Riverside Methodist Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medtronic Transcatheter Aortic Valve 2.0 Replacement System; Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System	Device: Medtronic Transcatheter Aortic Valve 2.0 Replacement System; Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause Mortality Rate	30 days
Stroke (Disabling) Rate	30 days
The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components:	All-cause mortality>; All stroke (disabling and non-disabling)>; Life-threatening bleeding>; Acute kidney injury: stage 2 or 3 (including renal replacement therapy)>; Coronary artery obstruction requiring intervention>; Major vascular complication>; Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)	30 days
Percentage of Participants With Life Threatening or Disabling Bleeding	Percentage of participants with life threatening or disabling bleeding - VARC-II definitions	30 days
Percentage of Participants With Major Vascular Complication	Percentage of participants with major vascular complication - VARC-II definition	30 days
Percentage of Participants With Coronary Artery Obstruction	Percentage of participants with coronary artery obstruction - VARC-II definitions	30 days
Percentage of Patient With Acute Kidney Injury- Stage 2 or 3	Percentage of participants with Acute kidney injury - Stage 2 or 3 - VARC-II definitions	30 days
Percentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure	Percentage of participants with valve-related dysfunction requiring repeat procedure - VARC-II definition	30 days
Device Success Rate (VARC II)		24 hours to 7 days
Hemodynamic Performance - Aortic Valve Area	Aortic Valve Area (cm2) by transthoracic echocardiogram	30 days
Hemodynamic Performance - Mean Gradient	Mean gradient (mmHg) by transthoracic echocardiogram	30 days
Hemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace	Total prosthetic regurgitation by transthoracic echocardiogram	30 days

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: Principal Investigator: John Forrest, MD, Yale New Haven Hospital; Principal Investigator: Mathew Williams, MD, NYU Langone Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 15, 2021

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 13, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 10233065DOC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO