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

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.

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®.

Inclusion Criteria:

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

Exclusion Criteria:

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