Non-valvular Atrial Fibrillation
Conditions
Keywords
Non-valvular atrial fibrillation, Atrial Fibrillation, Stroke, Left Atrial Appendage (LAA), LAA Closure, LAA Occlusion, WaveCrest
Brief summary
The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System in the current medical practice setting in patients with non-valvular atrial fibrillation who are at increased risk for stroke. Up to 65 subjects may be enrolled at up to 15 study sites in Europe. Patients will be followed through 45 days post-procedure.
Detailed description
The Coherex WaveCrest® Left Atrial Appendage Occlusion System is designed to permanently occlude the Left Atrial Appendage (LAA).
Interventions
DRUGAnticoagulation or Clopidogrel
Subjects either continue on anticoagulation or receive clopidogrel
DEVICEPercutaneous LAA Closure
LAA Closure with the WaveCrest LAA Occlusion System (study device)
Sponsors
Coherex Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The criteria for implant are in accordance to the current version of the Instructions for Use: Inclusion Criteria: 1. Non-valvular paroxysmal, persistent, or permanent atrial fibrillation 2. 18 years of age or older 3. LAA anatomy amenable to treatment by percutaneous techniques 4. Risk factors for potential thrombus formation in the LAA 5. Willing to participate in the required follow-up visits and tests 6. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee or Institutional Review Board at the study site
Exclusion criteria
1. Known contraindication to percutaneous transseptal intervention 2. Left atrial appendage anatomy or size that will not allow appropriate implantation of the WaveCrest Implant 3. Intracardiac thrombus or other cardiac abnormality visualized prior to implant that would significantly impact procedural safety 4. Mitral valve stenosis \< 1.5 cm2 or any stenosis consistent with rheumatic valvular disease or history of mitral valve replacement or repair 5. Known contraindication and/or allergy to nickel 6. Known active bacterial infection (i.e., sepsis, endocarditis) 7. Any known medical condition or overall health of the subject that could adversely affect procedural safety or potentially prevent the patient from completing all study required visits and tests. 8. Pregnant or breastfeeding women due to the risk of exposure to x-rays and medications associated with the implant procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint) | From baseline up to 45 days | The primary safety outcome was the composite of death from any cause (all-cause mortality), pericardial effusion requiring intervention, device embolization (major), device thrombus and ischemic stroke up to 45 days. The analysis was based on Sponsor Assessment of Adverse Events data. Baseline was defined as the last available measurement on or before the date of the implantation procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Device Success | From baseline up to 45 days | Percentage of participants who achieved device success were reported. Device success was defined as the percentage of participants who had the device deployed and implanted in the correct position. Baseline was defined as the last available measurement on or before the date of the implantation procedure. |
| Percentage of Participants Who Achieved Technical Success | From baseline up to 45 days | Percentage of participants who achieved technical success were reported. Technical success was defined as the percentage of participants who experienced successful placement and release of the occluder in the LAA with LAA closure (defined as no leak greater than \[\>\]5 millimeters \[mm\] on color Doppler transesophageal echocardiogram \[TEE\]) and who were discharged from the cardiac catheterization laboratory without the occurrence of device-related complications. Baseline was defined as the last available measurement on or before the date of the implantation procedure. |
| Percentage of Participants Who Achieved Procedural Success | From baseline up to 45 days | Percentage of participants who achieved procedural success were reported. Procedural success was defined as the percentage of participants who experienced successful placement and release of the occluder in the LAA with LAA closure (defined as no leak \>5 mm on color Doppler TEE) and who were discharged from the cardiac catheterization laboratory without device-related complications and without procedure-related complications other than minor device embolization (defined as device embolization that can be resolved by percutaneous technique without surgical intervention or damage to surrounding cardiovascular structures). Baseline was defined as the last available measurement on or before the date of the implantation procedure. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System In eligible participants, Coherex WaveCrest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Participant was treated with another device | 1 |
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System |
|---|---|
| Age, Continuous | 75.8 Years STANDARD_DEVIATION 7.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 24 |
| other Total, other adverse events | 6 / 24 |
| serious Total, serious adverse events | 6 / 24 |
Outcome results
Primary
Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint)
The primary safety outcome was the composite of death from any cause (all-cause mortality), pericardial effusion requiring intervention, device embolization (major), device thrombus and ischemic stroke up to 45 days. The analysis was based on Sponsor Assessment of Adverse Events data. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
Time frame: From baseline up to 45 days
Population: The intent-to-treat (ITT) analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System | Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint) | All-cause mortality | 2 Participants |
| Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System | Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint) | Pericardial effusion requiring intervention | 2 Participants |
| Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System | Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint) | Device embolization (major) | 1 Participants |
| Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System | Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint) | Device thrombus | 0 Participants |
| Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System | Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint) | Ischemic stroke | 0 Participants |
Secondary
Percentage of Participants Who Achieved Device Success
Percentage of participants who achieved device success were reported. Device success was defined as the percentage of participants who had the device deployed and implanted in the correct position. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
Time frame: From baseline up to 45 days
Population: The ITT analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System | Percentage of Participants Who Achieved Device Success | 83.3 Percentage of Participants |
Secondary
Percentage of Participants Who Achieved Procedural Success
Percentage of participants who achieved procedural success were reported. Procedural success was defined as the percentage of participants who experienced successful placement and release of the occluder in the LAA with LAA closure (defined as no leak \>5 mm on color Doppler TEE) and who were discharged from the cardiac catheterization laboratory without device-related complications and without procedure-related complications other than minor device embolization (defined as device embolization that can be resolved by percutaneous technique without surgical intervention or damage to surrounding cardiovascular structures). Baseline was defined as the last available measurement on or before the date of the implantation procedure.
Time frame: From baseline up to 45 days
Population: The ITT analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System | Percentage of Participants Who Achieved Procedural Success | 75.0 Percentage of Participants |
Secondary
Percentage of Participants Who Achieved Technical Success
Percentage of participants who achieved technical success were reported. Technical success was defined as the percentage of participants who experienced successful placement and release of the occluder in the LAA with LAA closure (defined as no leak greater than \[\>\]5 millimeters \[mm\] on color Doppler transesophageal echocardiogram \[TEE\]) and who were discharged from the cardiac catheterization laboratory without the occurrence of device-related complications. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
Time frame: From baseline up to 45 days
Population: The ITT analysis set consisted of all participants who signed the informed consent form, met all of the inclusion criteria and none of the exclusion criteria, and the Coherex Delivery sheath had been inserted into the participant's femoral vein.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System | Percentage of Participants Who Achieved Technical Success | 79.2 Percentage of Participants |