NCT06203054

CLIP-IT Post-Market Study

exClusion of the Left atrIal Appendage With PendITure™ (CLIP-IT) Post-Market Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Medtronic Cardiac Surgery · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect post-market clinical evidence on performance and clinical outcomes of the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.

Detailed description

Multi center, single-arm, nonrandomized, interventional, unblinded, post-market study. Up to 150 subjects will be enrolled and implanted with the Penditure™ Left Atrial Appendage (LAA) Exclusion Clip at up to 25 sites in the United States. Subjects will be followed at 30 days, 3 months, 12-months and annually for 36-months.

Conditions

• Left Atrial Appendage Exclusion

Interventions

Type	Name	Description
DEVICE	Penditure™ Left Atrial Appendage (LAA) Exclusion System	Exclusion of the left atrial appendage using the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.

Timeline

• Start date: 2024-02-26
• Primary completion: 2025-08-26
• Completion: 2029-02-01
• First posted: 2024-01-12
• Last updated: 2025-10-28

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study