The Medtronic TAVR 2.0 US Clinical Study

Aortic Valve Stenosis Clinical Trial

Official title:

The Medtronic TAVR 2.0 US Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738853
• Other study ID #: 10233065DOC
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 15, 2021

Study information

• Verified date: March 2023
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 15, 2021
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Mortality Rate		30 days
Primary	Stroke (Disabling) Rate		30 days
Primary	The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram		30 days
Secondary	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
Secondary	Percentage of Participants With Life Threatening or Disabling Bleeding	Percentage of participants with life threatening or disabling bleeding - VARC-II definitions	30 days
Secondary	Percentage of Participants With Major Vascular Complication	Percentage of participants with major vascular complication - VARC-II definition	30 days
Secondary	Percentage of Participants With Coronary Artery Obstruction	Percentage of participants with coronary artery obstruction - VARC-II definitions	30 days
Secondary	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
Secondary	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
Secondary	Device Success Rate (VARC II)		24 hours to 7 days
Secondary	Hemodynamic Performance - Aortic Valve Area	Aortic Valve Area (cm2) by transthoracic echocardiogram	30 days
Secondary	Hemodynamic Performance - Mean Gradient	Mean gradient (mmHg) by transthoracic echocardiogram	30 days
Secondary	Hemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace	Total prosthetic regurgitation by transthoracic echocardiogram	30 days