Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

Summary

Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Plan (MAC CAP). Subjects in the Randomized cohort were randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts were receive the trial device.

The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) was to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification.

This randomized controlled trial would provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System would be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who were not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and were also not suitable for transcatheter repair with MitraClip, would be enrolled in the Non-repairable cohort.

Subjects would be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.

Conditions

• Mitral Regurgitation
• Mitral Insufficiency
• Mitral Valve Insufficiency
• Cardiovascular Diseases
• Valve Disease, Heart
• Heart Valve Diseases
• Functional Mitral Regurgitation
• Degenerative Mitral Valve Disease

Interventions

DEVICE

Tendyne Mitral Valve System

Mitral valve replacement

DEVICE

MitraClip System

Percutaneous mitral valve repair using the MitraClip system.

Sponsors & Collaborators

• Abbott Medical Devices

  lead INDUSTRY

Principal Investigators

• Gorav Ailawadi, MD · University of Michigan

• Jason Rogers, MD · University of California, Davis

• Kyle Brunner, PhD · Abbott Structural Heart

• Paul Sorajja, MD · Allina Health System

• Vinod Thourani, MD · Piedmont Healthcare and the Marcus Heart Valve Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-15

Primary Completion

2024-04-29

Completion

2028-06-30

FDA Device

Yes

Countries

• United States
• Canada

Study Locations