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

N/ACompletedNCT05101993

AtriCure, Inc.156 enrolled

Overview

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®.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

156

Conditions

Left Atrial Appendage Absent

Interventions

AtriClipDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (11)

Franciscan Health

Indianapolis, Indiana, United States

Washington University School of Medicine

St Louis, Missouri, United States

Albany Medical College

Albany, New York, United States

Outcomes

Primary Outcomes

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.

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

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

Time frame: 30-days post-procedure

Secondary Outcomes

Performance

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

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

Long-term Thromboembolic Events

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

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

Device and Procedure Long-term Safety

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

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

Data from ClinicalTrials.gov

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