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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-27

Study Completion Date

2024-07-22

Brief Summary

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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.

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Detailed Description

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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

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Left Atrial Appendage Absent

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AtriClip group

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.

Group Type EXPERIMENTAL

AtriClip

Intervention Type DEVICE

Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure

Interventions

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AtriClip

Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes