Left Atrial Appendage Absent
Conditions
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.
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®.
Interventions
DEVICEAtriClip
Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure
Sponsors
AtriCure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Performance Endpoint | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance | 12-months or greater post-procedure, an average of 1.5 years | A residual LAA neck ≤10 mm as assessed by CTA or TEE imaging at the last follow-up visit |
| Long-term Thromboembolic Events | 12-months or greater post-procedure, an average of 1.5 years | Incidence of thromboembolic events (ischemic stroke, TIA, systemic embolism) of any cause through the last follow-up visit. |
| Device and Procedure Long-term Safety | 12-months or greater post-procedure, an average of 1.5 years | Number of Participants with Device or Procedure Related SAEs through the last follow-up visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AtriClip Group AtriClip: Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure | 155 |
| Total | 155 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | AtriClip Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 94 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants |
| Age, Continuous | 66 years |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black | 5 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized White | 146 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 155 |
| other Total, other adverse events | 0 / 155 |
| serious Total, serious adverse events | 76 / 155 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AtriClip Group | Primary Performance Endpoint | 151 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AtriClip Group | Primary Safety Endpoint | 0 Participants |
p-value: <0.0001Chi-squared
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AtriClip Group | Device and Procedure Long-term Safety | 5 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AtriClip Group | Long-term Thromboembolic Events | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AtriClip Group | Performance | 135 Participants |