Trial Outcomes & Findings for VCLIP Post-Market Study, Long-term Follow-up on LAA Exclusion Using AtriClip (NCT NCT05101993)
NCT ID: NCT05101993
Last Updated: 2025-07-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
156 participants
Primary outcome timeframe
12-months or greater post-procedure, an average of 1.5 years
Results posted on
2025-07-03
Participant Flow
Participant milestones
| Measure |
AtriClip Group
AtriClip: Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure
|
|---|---|
|
Overall Study
STARTED
|
156
|
|
Overall Study
COMPLETED
|
155
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
AtriClip Group
AtriClip: Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
1 subject withdrew participation prior to index procedure
Baseline characteristics by cohort
| Measure |
AtriClip Group
n=155 Participants
AtriClip: Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • 1 subject withdrew participation prior to index procedure
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=5 Participants • 1 subject withdrew participation prior to index procedure
|
|
Age, Categorical
>=65 years
|
94 Participants
n=5 Participants • 1 subject withdrew participation prior to index procedure
|
|
Age, Continuous
|
66 years
n=5 Participants • 1 subject withdrew participation before index procedure
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants • Measure Analysis Population Description: 1 subject withdrew participation prior to index procedure
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants • Measure Analysis Population Description: 1 subject withdrew participation prior to index procedure
|
|
Race/Ethnicity, Customized
White
|
146 Participants
n=5 Participants • 1 subject withdrew participation before index procedure
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants • 1 subject withdrew participation before index procedure
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants • 1 subject withdrew participation before index procedure
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants • 1 subject withdrew participation before index procedure
|
PRIMARY outcome
Timeframe: 12-months or greater post-procedure, an average of 1.5 yearsLeft 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.
Outcome measures
| Measure |
AtriClip Group
n=151 Participants
AtriClip: Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure
|
|---|---|
|
Primary Performance Endpoint
|
151 Participants
|
PRIMARY outcome
Timeframe: 30-days post-procedureIncidence 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
Outcome measures
| Measure |
AtriClip Group
n=155 Participants
AtriClip: Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure
|
|---|---|
|
Primary Safety Endpoint
|
0 Participants
|
SECONDARY outcome
Timeframe: 12-months or greater post-procedure, an average of 1.5 yearsA residual LAA neck ≤10 mm as assessed by CTA or TEE imaging at the last follow-up visit
Outcome measures
| Measure |
AtriClip Group
n=152 Participants
AtriClip: Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure
|
|---|---|
|
Performance
|
135 Participants
|
SECONDARY outcome
Timeframe: 12-months or greater post-procedure, an average of 1.5 yearsIncidence of thromboembolic events (ischemic stroke, TIA, systemic embolism) of any cause through the last follow-up visit.
Outcome measures
| Measure |
AtriClip Group
n=155 Participants
AtriClip: Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure
|
|---|---|
|
Long-term Thromboembolic Events
|
0 Participants
|
SECONDARY outcome
Timeframe: 12-months or greater post-procedure, an average of 1.5 yearsNumber of Participants with Device or Procedure Related SAEs through the last follow-up visit
Outcome measures
| Measure |
AtriClip Group
n=155 Participants
AtriClip: Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure
|
|---|---|
|
Device and Procedure Long-term Safety
|
5 Participants
|
Adverse Events
AtriClip Group
Serious events: 76 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AtriClip Group
n=155 participants at risk
AtriClip: Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure
|
|---|---|
|
Cardiac disorders
Arrhythmia Needing Medical Treatment (new onset)
|
5.8%
9/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Blood and lymphatic system disorders
Pleural Effusion
|
4.5%
7/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Blood and lymphatic system disorders
Bleeding Event
|
1.9%
3/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Gastrointestinal disorders
GI Bleed
|
1.9%
3/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
2.6%
4/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Immune system disorders
Sepsis
|
1.9%
3/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Cardiac disorders
Angina
|
1.3%
2/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Gastrointestinal disorders
Bowel Obstruction
|
1.9%
3/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Cardiac disorders
Vascular Disease
|
1.9%
3/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.3%
2/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Immune system disorders
Conduction Disturbance
|
1.3%
2/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Cardiac disorders
Congestive Heart Failure
|
1.3%
2/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Cardiac disorders
Myocardial Infraction
|
1.3%
2/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Cardiac disorders
Pericardial Effusion
|
1.3%
2/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
2/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.3%
2/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Nervous system disorders
TIA or Neurological Deficit
|
1.3%
2/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Nervous system disorders
Aphasia
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Cardiac disorders
Atrial Fibrillation with Rapid Ventricular rate
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Cardiac disorders
AV block requiring permanent pacemaker (new onset)
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Infections and infestations
Infection
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Surgical and medical procedures
Left foot partial 1st ray amputation
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
General disorders
Nausea and Abdominal Pain-Dehydration
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Cardiac disorders
Pericarditis
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Surgical and medical procedures
Post operative ileus requiring decompressive colonoscopy
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Cardiac disorders
Pulmonary Embolism
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Renal and urinary disorders
Renal Insufficiency
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Cardiac disorders
Sinus Node Dysfunction
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Cardiac disorders
Sternal Dehiscence
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Cardiac disorders
Stroke, Other (Cardioembolic)
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Cardiac disorders
Stroke, Ischemic
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Cardiac disorders
Thrombus
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Cardiac disorders
Thrombocytopenia
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
Cardiac disorders
Tricuspid Valve Regurgitation
|
0.65%
1/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
|
General disorders
Excessive Bleeding r/t Procedure (req >2u Blood or intervention)
|
1.3%
2/155 • 12-months or greater post-procedure, an average of 1.5 years
Serious Adverse Events
|
Other adverse events
Adverse event data not reported
Additional Information
Randall Lee, VP Medical Affairs, Clinical Affairs
AtriCure
Phone: 650-347-0419
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place