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.

Study Overview

• Status: Active, not recruiting
• Conditions: Left Atrial Appendage Absent
• Intervention / Treatment: Device: AtriClip

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan Health
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • New York, New York, United States, 10032
      • Columbia University
    • New York, New York, United States, 10029
      • Mount Sinai
    • New York, New York, United States, 10016
      • NYU
  • Ohio
    • Cincinnati, Ohio, United States, 45237
      • Mercy Health Cincinnati
    • Toledo, Ohio, United States, 43604
      • Toledo Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29601
      • Prisma Health
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Centra Lynchburg General Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Research Institute LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AtriClip group	Device: AtriClip; Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Performance Endpoint	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.	12-months or greater post-procedure
Primary Safety Endpoint	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	30-days post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance	A residual LAA neck ≤10 mm as assessed by CTA or TEE imaging at the last follow-up visit	12-months or greater post-procedure
Long-term thromboembolic events	Incidence of thromboembolic events (ischemic stroke, TIA, systemic embolism) of any cause through the last follow-up visit.	12-months or greater post-procedure
Device and Procedure long-term Safety	Device or procedure related SAEs through the last follow-up visit	12-months or greater post-procedure

Collaborators and Investigators

• Sponsor: AtriCure, Inc.
• Investigators: Principal Investigator: Elias Zias, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Estimated): August 31, 2023

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CP-2021-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes