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

Not Applicable

Completed

• Conditions: Mitral Annular Calcification; Mitral Annulus Calcification; Cardiovascular Diseases; Heart Valve Calcification; Mitral Insufficiency; Valve Heart Disease; Mitral Valve Disease; Heart Valve Diseases; Mitral Regurgitation
• Interventions: Device: Tendyne Mitral Valve System

• Registration Number: NCT03539458
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-05-16
• Study First Posted: 2018-05-29
• Study Start: 2018-10-10
• Primary Completion: 2019-11-29
• Results First Submitted: 2020-11-30
• Results First Submitted QC: 2021-01-07
• Results First Posted: 2021-01-26
• Study Completion: 2024-06-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device Arm	Tendyne Mitral Valve System	All subjects will undergo procedure with the Tendyne Mitral Valve System.

Primary Outcome Measures

Name	Time	Method
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)	30 days post implant	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

Trial Locations

Locations (4)

Cardiovascular Research Institute of Kansas; 🇺🇸 Wichita, Kansas, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Abbott Northwestern Hospital; 🇺🇸 Minneapolis, Minnesota, United States

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States