Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification

NCT ID: NCT03539458

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2024-06-18

Brief Summary

This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification (MAC). Subjects satisfying the study inclusion/exclusion criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.

Conditions

Mitral Regurgitation; Mitral Insufficiency; Mitral Annular Calcification; Mitral Annulus Calcification; Cardiovascular Diseases; Valve Heart Disease; Heart Valve Diseases; Heart Valve Calcification; Mitral Valve Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device Arm

All subjects will undergo procedure with the Tendyne Mitral Valve System.

Group Type: EXPERIMENTAL

Tendyne Mitral Valve System

Intervention Type: DEVICE

Mitral valve replacement

Interventions

Tendyne Mitral Valve System

Mitral valve replacement

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Heart Team determines subject is not a suitable candidate for conventional surgical treatment due to degree of MAC present and the subject will likely benefit from transcatheter valve implantation

2. Symptomatic, severe mitral regurgitation, as defined in the 2017 ACC expert Consensus Decision Pathway on the Management of MR

3. NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)

4. Age 18 years or older at time of consent

5. Not a member of a vulnerable population per the investigator's judgment

6. The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions, including complying with study required testing and follow-up visits, and has provided written informed consent

Exclusion Criteria

1. Presence of Left Ventricle or Left Atrium thrombus

2. Chest condition that prevents transapical access

3. Left Ventricular Ejection Fraction (LVEF) less than 25% assessed by echocardiogram

4. Left Ventricular End Diastolic Dimension (LVEDD) > 7.0 cm

5. Severe mitral stenosis not amenable to balloon valvuloplasty or transcatheter therapy

6. Prior intervention with permanently implanted mitral device (e.g. MitraClip)

7. Mitral pathoanatomy and Left Ventricular Outflow tract (LVOT) anatomy deemed not suitable for Tendyne mitral valve implantation

8. Any planned cardiac surgery or intervention that is 30 days prior and 30 days post that is not concomitant with the Tendyne procedure

9. Cardiac resynchronization therapy (CRT) device or implantable pulse generator (IPG) implanted within three months of planned implant procedure

10. Myocardial Infarction (MI) within 30 days of the planned implant procedure

11. Symptomatic, or ischemia-associated coronary artery disease (e.g., active ischemia) amenable to revascularization and thus requiring stenting or CABG

12. Cerebrovascular accident (CVA) within six months of planned implant procedure

13. Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound)

14. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices within 1 month prior to planned implant procedure

15. Severe tricuspid regurgitation or severe right ventricular dysfunction

16. Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology

17. Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy if cannot be adequately treated

18. History of endocarditis within 6 months of planned implant procedure

19. Active systemic infection requiring antibiotic therapy

20. Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anti-coagulation therapy) which cannot be adequately managed medically

21. Subject unable or unwilling to take anticoagulation with warfarin for a minimum of 6 months following Tendyne valve implantation

22. Known hypersensitivity to nickel or titanium

23. Subject is undergoing hemodialysis due to chronic renal failure ( ≥ Stage 4 CKD)

24. Subject has pulmonary arterial hypertension (fixed PAS >70mmHg)

25. FEV1 < 50% of predicted or < 1L

26. Subject refuses blood transfusions

27. Subject has COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use

28. Pregnant, lactating, or planning pregnancy within next 12 months.

29. Currently participating in an investigational drug or another device trial that has not reached its primary endpoint

30. Subjects with non-cardiac co-morbidities that are likely to result in a life expectancy of less than 12 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Sorajja, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Heart Institute - Abbott Northwestern Hospital

Vinod Thourani, MD

Role: PRINCIPAL_INVESTIGATOR

Piedmont Heart Hospital

Locations

Emory University Hospital

Atlanta, Georgia, United States

Cardiovascular Research Institute of Kansas

Wichita, Kansas, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CS0005-P

Identifier Type: -

Identifier Source: org_study_id