NCT05101993

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 1, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 27, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2024

Completed
11 months until next milestone

Results Posted

Study results publicly available

June 24, 2025

Completed
Last Updated

July 3, 2025

Status Verified

April 1, 2023

Enrollment Period

1.2 years

First QC Date

October 20, 2021

Results QC Date

November 26, 2024

Last Update Submit

June 26, 2025

Conditions

Left Atrial Appendage Absent

Outcome Measures

Primary Outcomes (2)

  • 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, 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

    30-days post-procedure

Secondary Outcomes (3)

  • Performance

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

  • Long-term Thromboembolic Events

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

  • Device and Procedure Long-term Safety

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

Study Arms (1)

AtriClip group

EXPERIMENTAL

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.

Device: AtriClip

Interventions

AtriClipDEVICE

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

AtriClip group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Franciscan Health

Indianapolis, Indiana, 46237, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

NYU

New York, New York, 10016, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Mercy Health Cincinnati

Cincinnati, Ohio, 45237, United States

Location

Toledo Hospital

Toledo, Ohio, 43604, United States

Location

Prisma Health

Greenville, South Carolina, 29601, United States

Location

Centra Lynchburg General Hospital

Lynchburg, Virginia, 24501, United States

Location

Aurora Research Institute LLC

Milwaukee, Wisconsin, 53215, United States

Location

Results Point of Contact

Title
Randall Lee, VP Medical Affairs, Clinical Affairs
Organization
AtriCure
RLee@atricure.com
650-347-0419

Study Officials

  • Elias Zias, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 1, 2021

Study Start

January 27, 2022

Primary Completion

March 31, 2023

Study Completion

July 22, 2024

Last Updated

July 3, 2025

Results First Posted

June 24, 2025

Record last verified: 2023-04

Locations

US(11)