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

Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Heart Valve Diseases; Mitral Regurgitation; Mitral Insufficiency; Valve Heart Disease; Mitral Annulus Calcification; Mitral Valve Disease; Mitral Annular Calcification; Heart Valve Calcification
• Intervention / Treatment: Device: Tendyne Mitral Valve System

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Cardiovascular Research Institute of Kansas
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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: Device Arm; All subjects will undergo procedure with the Tendyne Mitral Valve System.	Device: Tendyne Mitral Valve System; Mitral valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Composite Endpoint of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs), as Classified by the Clinical Events Committee (CEC)	Definition of Device Success: All of the following must be present: Absence of procedural mortality or stroke; and; Proper placement and positioning of the device, and; Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and; Continued intended safety and performance of the device, including: i. No evidence of structural or functional failure ii. No specific device-related technical failure issues or complications iii. Reduction of MR to either optimal or acceptable levels without significant structural valve dysfunction and with no greater than mild (1+) paravalvular MR (and without associated hemolysis). All device- or procedure-related adverse events will be adjudicated by an independent clinical events committee	30 days post implant

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Kartik Sundareswaran, PhD, Abbott Structural Heart; Principal Investigator: Paul Sorajja, MD, Minneapolis Heart Institute - Abbott Northwestern Hospital; Principal Investigator: Vinod Thourani, MD, Piedmont Heart Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): November 29, 2019
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Heart Diseases; Cardiovascular Diseases; Mitral Valve Insufficiency; Heart Valve Diseases; Calcinosis
• Other Study ID Numbers: CS0005-P

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes