NCT03433274

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Tendyne Mitral Valve System	Mitral valve replacement
DEVICE	MitraClip System	Percutaneous mitral valve repair using the MitraClip system.

Timeline

• Start date: 2018-06-15
• Primary completion: 2024-04-29
• Completion: 2028-06-01
• First posted: 2018-02-14
• Last updated: 2026-03-12
• Results posted: 2026-01-08

Locations

78 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study