Left Atrial Appendage AbsentVCLIPNCT05101993
VCLIP Post-Market Study, Long-term Follow-up on LAA Exclusion Using AtriClip
A study testing AtriClip in people with Left Atrial Appendage Absent, run by AtriCure, Inc. at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Left Atrial Appendage Absent
- What is being tested?
- AtriClip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 11 sitesUnited States
- Study dates
- 27 Jan 2022to 22 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Inability, unwillingness, or contraindication to undergo TEE or CTA imaging
- Subjects who are pregnant or breast feeding
- Subjects with active COVID-19 infection
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Albany Medical College
Albany, New York, 12208
Mercy Health Cincinnati
Cincinnati, Ohio, 45237
Prisma Health
Greenville, South Carolina, 29601
Franciscan Health
Indianapolis, Indiana, 46237
Centra Lynchburg General Hospital
Lynchburg, Virginia, 24501
Aurora Research Institute LLC
Milwaukee, Wisconsin, 53215
NYU
New York, New York, 10016
Mount Sinai
New York, New York, 10029
Columbia University
New York, New York, 10032
Washington University School of Medicine
St Louis, Missouri, 63110
Toledo Hospital
Toledo, Ohio, 43604
About this study
Official title: Long-term Follow-up on LAA Exclusion Using AtriClip, VCLIP Post-Market Study, CLINICAL TRIAL PROTOCOL: CP-2021-03
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.
Read the detailed description
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
- Left Atrial Appendage Absent
- Being tested
- AtriClip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtriClipDevice
Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AtriClip |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 30-days post-procedure
Secondary outcomes (3)
Performance
A residual LAA neck ≤10 mm as assessed by CTA or TEE imaging at the last follow-up visit
Measured: 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.
Measured: 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
Measured: 12-months or greater post-procedure, an average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start27 Jan 2022
- Primary completion31 Mar 2023
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Left Atrial Appendage AbsentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- AtriCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elias Zias, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101993
- Sponsor's protocol ID
- CP-2021-03
- Acronym
- VCLIP
- Status last verified
- Apr 2023
- First submitted
- 20 Oct 2021
- Last updated
- 3 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up on LAA Exclusion Using AtriClip, VCLIP Post-Market Study, CLINICAL TRIAL PROTOCOL: CP-2021-03
- ClinicalTrials.gov ID
- NCT05101993
- Acronym / sponsor ID
- VCLIP / CP-2021-03
- Conditions
- Left Atrial Appendage Absent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- AtriCure, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Posted 24 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AtriClip group | Experimental | Device: AtriClipSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Inability, unwillingness, or contraindication to undergo TEE or CTA imaging
- Subjects who are pregnant or breast feeding
- Subjects with active COVID-19 infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtriClipReceived AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure | Device | AtriClip group |
Primary outcome
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.
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
3 secondary outcomes
Performance
Time frame: 12-months or greater post-procedure, an average of 1.5 years
Long-term Thromboembolic Events
Time frame: 12-months or greater post-procedure, an average of 1.5 years
Device and Procedure Long-term Safety
Time frame: 12-months or greater post-procedure, an average of 1.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Left Atrial Appendage Absent
RecruitingPhase 4
Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)
Atrial Fibrillation, Left Atrial Appendage Absent
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elias Zias, MD principal investigator
NYU Langone Health
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AtriClip in people with Left Atrial Appendage Absent, run by AtriCure, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Performance Endpoint (time frame: 12-months or greater post-procedure, an average of 1.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.