NCT05101993

VCLIP Post-Market Study, Long-term Follow-up on LAA Exclusion Using AtriClip

Long-term Follow-up on LAA Exclusion Using AtriClip, VCLIP Post-Market Study, CLINICAL TRIAL PROTOCOL: CP-2021-03

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: AtriCure, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Retrospective-prospective, multi-center, non-randomized, unblinded, post-market study to evaluate the long-term performance and safety of AtriClip® FLEX-V LAA and PRO•V LAA Exclusion devices for exclusion of the left atrial appendage of the heart during concomitant cardiac procedures.

Detailed description

The goal of this clinical trial is to evaluate the long-term performance and safety of AtriClip® FLEX-V LAA and PRO•V LAA Exclusion devices for exclusion of the left atrial appendage of the heart during concomitant cardiac procedures in participants for which a VCLIP was placed previously. Participants are consented and evaluated to confirm long-term performance of the AtriClip®.

Conditions

• Left Atrial Appendage Absent

Interventions

Type	Name	Description
DEVICE	AtriClip	Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure

Timeline

• Start date: 2022-01-27
• Primary completion: 2023-03-31
• Completion: 2024-07-22
• First posted: 2021-11-01
• Last updated: 2025-07-03
• Results posted: 2025-06-24

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study