Skip to main content
OpenTrials
Completed

NCT Number: NCT05101993

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Left Atrial Appendage Absent

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Franciscan Health, Indianapolis, Indiana, United States

Loading trial locations.

About this study

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®.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

AtriClip

Device

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

Primary outcomes

  1. Primary Performance Endpoint

    Time frame: 12-months or greater post-procedure, an average of 1.5 years

    Left Atrial Appendage exclusion defined as absence of residual communication (≤3 mm residual communication with LAA) between the left atrium (LA) and the LAA as assessed by CTA or TEE imaging at the last follow-up visit. The images will be reviewed by an independent core lab using a standardized imaging protocol.

  2. Primary Safety Endpoint

    Time frame: 30-days post-procedure

    Incidence of the following serious adverse events within 30-days, if related tot he device and/or implant procedure:

    • Death
    • Ischemic Stroke
    • Transient Ischemic Attack
    • Systemic Embolism
    • Hemorrhagic Stroke
    • Major Bleeding (BARC 3 and above)
    • Surgical site infection
    • Pericardial effusion requiring intervention
    • Clinical diagnosis of myocardial infarction

Secondary outcomes

  1. Performance

    Time frame: 12-months or greater post-procedure, an average of 1.5 years

    A residual LAA neck ≤10 mm as assessed by CTA or TEE imaging at the last follow-up visit

  2. Long-term Thromboembolic Events

    Time frame: 12-months or greater post-procedure, an average of 1.5 years

    Incidence of thromboembolic events (ischemic stroke, TIA, systemic embolism) of any cause through the last follow-up visit.

  3. Device and Procedure Long-term Safety

    Time frame: 12-months or greater post-procedure, an average of 1.5 years

    Number of Participants with Device or Procedure Related SAEs through the last follow-up visit

Sponsors and collaborators

Lead sponsor

AtriCure, Inc.

Industry

Registry information

Official study title

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

Acronym: VCLIP

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 1, 2021
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.