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

AtriCure

Status: Completed

Conditions: Left Atrial Appendage Absent

Treatments: Device: AtriClip

Study type: Interventional

Funder types: Industry

Identifiers

NCT05101993

CP-2021-03

Details and patient eligibility

About

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.

Full 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®.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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156 participants in 1 patient group

AtriClip group

Experimental group

Description:

Subjects eligible for evaluation are those who had undergone designated non-emergent, cardiac surgical procedure(s), received an AtriClip implant (with devices under investigation) and who were willing to return for follow-up chest imaging to ascertain Left Atrial Appendage (LAA) exclusion and met inclusion exclusion criteria.

Treatment:

Device: AtriClip