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

Completed · Not applicable

Conditions studied: Left Atrial Appendage Absent

In brief

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.

Key facts

Study ID

NCT05101993

Run by

AtriCure, Inc.

People needed

156

Starts

2022-01-27

Expected to finish

2024-07-22

Last updated by the study team

2025-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is greater than or equal to 18 years of age.
• Subject who received the AtriClip FLEX-V or PRO•V implant during a non-emergent cardiac surgical procedure
• Subject is willing and able to provide written informed consent
• Subject is willing and able to return for scheduled follow-up visit and imaging (CTA or TEE)

You may not qualify if…

• Inability, unwillingness, or contraindication to undergo TEE or CTA imaging
• Subjects who are pregnant or breast feeding
• Subjects with active COVID-19 infection

Where it is running

• Franciscan Health — Indianapolis, Indiana, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Albany Medical College — Albany, New York, United States
• NYU — New York, New York, United States
• Mount Sinai — New York, New York, United States
• Columbia University — New York, New York, United States
• Mercy Health Cincinnati — Cincinnati, Ohio, United States
• Toledo Hospital — Toledo, Ohio, United States
• Prisma Health — Greenville, South Carolina, United States
• Centra Lynchburg General Hospital — Lynchburg, Virginia, United States
• Aurora Research Institute LLC — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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