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VCLIP Post-Market Study, Long-term Follow-up on LAA Exclusion Using AtriClip
NA trial testing AtriClip in Left Atrial Appendage Absent in 156 participants. Completed in 22 July 2024.
| Lead sponsor | AtriCure, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 156 |
| Start date | 27 January 2022 |
| Primary completion | 31 March 2023 |
| Estimated completion | 22 July 2024 |
| Sites | 11 locations across United States |
AtriCure, Inc.
18 and older, any sex, with Left Atrial Appendage Absent. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| AtriClip Group | 151 |
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
| Group | Value | 95% CI |
|---|---|---|
| AtriClip Group | 0 |
A residual LAA neck ≤10 mm as assessed by CTA or TEE imaging at the last follow-up visit
| Group | Value | 95% CI |
|---|---|---|
| AtriClip Group | 135 |
Incidence of thromboembolic events (ischemic stroke, TIA, systemic embolism) of any cause through the last follow-up visit.
| Group | Value | 95% CI |
|---|---|---|
| AtriClip Group | 0 |
Number of Participants with Device or Procedure Related SAEs through the last follow-up visit
| Group | Value | 95% CI |
|---|---|---|
| AtriClip Group | 5 |
Time frame: 12-months or greater post-procedure, an average of 1.5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | AtriClip Group |
|---|---|---|
| Arrhythmia Needing Medical Treatment (new onset) | Cardiac disorders | — |
| Pleural Effusion | Blood and lymphatic system disorders | — |
| Hernia | Musculoskeletal and connective tissue disorders | — |
| Bleeding Event | Blood and lymphatic system disorders | — |
| GI Bleed | Gastrointestinal disorders | — |
| Sepsis | Immune system disorders | — |
| Bowel Obstruction | Gastrointestinal disorders | — |
| Vascular Disease | Cardiac disorders | — |
| Angina | Cardiac disorders | — |
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Conduction Disturbance | Immune system disorders | — |
| Congestive Heart Failure | Cardiac disorders | — |
| Myocardial Infraction | Cardiac disorders | — |
| Pericardial Effusion | Cardiac disorders | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| TIA or Neurological Deficit | Nervous system disorders | — |
| Excessive Bleeding r/t Procedure (req >2u Blood or intervention) | General disorders | — |
| Aphasia | Nervous system disorders | — |
| Atrial Fibrillation with Rapid Ventricular rate | Cardiac disorders | — |
| AV block requiring permanent pacemaker (new onset) | Cardiac disorders | — |
| Hemothorax | Respiratory, thoracic and mediastinal disorders | — |
| Infection | Infections and infestations | — |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | — |
| Left foot partial 1st ray amputation | Surgical and medical procedures | — |
Most-reported serious reactions: Arrhythmia Needing Medical Treatment (new onset), Pleural Effusion, Hernia, Bleeding Event, GI Bleed, Sepsis, Bowel Obstruction, Vascular Disease.
Data from ClinicalTrials.gov NCT05101993 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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