NCT07227675

Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional MR

Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional MR Continued Access Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The COAPT Continued Access Study (CAS) is an extension of the COAPT RCT under the same IDE (G120024). COAPT CAS was a single-arm, prospective, multicenter continued access registry that enrolled heart failure patients with secondary mitral regurgitation who remained symptomatic despite optimal guideline-directed medical therapy (GDMT). The objective of the COAPT CAS is to continue the evaluation of safety and effectiveness of the MitraClip NT System under more "real world" conditions in patients who meet the COAPT inclusion/exclusion criteria and who have national Medicare coverage by the Centers for Medicare and Medicaid Services (CMS).

Conditions

• Mitral Regurgitation
• Mitral Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	MitraClip® NT System	The MitraClip NT System is intended to treat heart failure patients with symptomatic ischemic or non-ischemic functional MR

Timeline

• Start date: 2017-10-23
• Primary completion: 2019-03-14
• Completion: 2024-03-31
• First posted: 2025-11-13
• Last updated: 2025-11-13

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated device study