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

NCT03539458 | Completed Results DMC FDA Device

• 1 other identifier: CS0005-P
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• 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: 1. Absence of procedural mortality or stroke; and 2. Proper placement and positioning of the device, and 3. Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and 4. 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

Study Arms (1)

Device Arm

EXPERIMENTAL

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

Device: Tendyne Mitral Valve System

Interventions

Tendyne Mitral Valve System DEVICE

Mitral valve replacement

Device Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Symptomatic, severe mitral regurgitation, as defined in the 2017 ACC expert Consensus Decision Pathway on the Management of MR
• NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)
• Age 18 years or older at time of consent
• Not a member of a vulnerable population per the investigator's judgment
• 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

You may not qualify if:

• Presence of Left Ventricle or Left Atrium thrombus
• Chest condition that prevents transapical access
• Left Ventricular Ejection Fraction (LVEF) less than 25% assessed by echocardiogram
• Left Ventricular End Diastolic Dimension (LVEDD) \> 7.0 cm
• Severe mitral stenosis not amenable to balloon valvuloplasty or transcatheter therapy
• Prior intervention with permanently implanted mitral device (e.g. MitraClip)
• Mitral pathoanatomy and Left Ventricular Outflow tract (LVOT) anatomy deemed not suitable for Tendyne mitral valve implantation
• Any planned cardiac surgery or intervention that is 30 days prior and 30 days post that is not concomitant with the Tendyne procedure
• Cardiac resynchronization therapy (CRT) device or implantable pulse generator (IPG) implanted within three months of planned implant procedure
• Myocardial Infarction (MI) within 30 days of the planned implant procedure
• Symptomatic, or ischemia-associated coronary artery disease (e.g., active ischemia) amenable to revascularization and thus requiring stenting or CABG
• Cerebrovascular accident (CVA) within six months of planned implant procedure
• Unresolved severe symptomatic carotid stenosis (\> 70% by ultrasound)
• Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices within 1 month prior to planned implant procedure
• Severe tricuspid regurgitation or severe right ventricular dysfunction

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (4)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency; Cardiovascular Diseases; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Results Point of Contact

• Title: Reshma Rao, Principal Study Clinical Research Associate
• Organization: Abbott Vascular Structural Heart

reshma.rao@abbott.com

651-756-2542

Study Officials

• Paul Sorajja, MD

  Minneapolis Heart Institute - Abbott Northwestern Hospital

  PRINCIPAL INVESTIGATOR

• Vinod Thourani, MD

  Piedmont Heart Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: May 29, 2018
• Study Start: October 10, 2018
• Primary Completion: November 29, 2019
• Study Completion: June 18, 2024
• Last Updated: November 18, 2024
• Results First Posted: January 26, 2021

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)