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Study closed due to device design modifications.
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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.
The Coherex WaveCrest® Left Atrial Appendage Occlusion System is designed to permanently occlude the Left Atrial Appendage (LAA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WaveCrest® | Experimental | Implant of WaveCrest® Left Atrial Appendage Occlusion System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous LAA Closure | Device | LAA Closure with the WaveCrest LAA Occlusion System (study device) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline up to 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline up to 45 days |
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The criteria for implant are in accordance to the current version of the Instructions for Use:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom De Potter, MD | OLV Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Hospital | Aalst | Belgium |
Site-specific clinical study results may be published by Investigators in compliance with the Investigator Agreement and/or site agreement, as applicable.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | From baseline up to 45 days |
|
From baseline up to 45 days
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. Baseline was defined as the last available measurement on or before the date of the implantation procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 19 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Clinical Research | Coherex Medical, Inc. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2018 | Mar 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 5, 2022 | Mar 26, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Anticoagulation or Clopidogrel | Drug | Subjects either continue on anticoagulation or receive clopidogrel |
|
| 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. | From baseline up to 45 days |
| 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. | From baseline up to 45 days |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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. |
|
|
| 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. | 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. | Posted | Number | Percentage of Participants | From baseline up to 45 days |
|
|
|
| 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. | 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. | Posted | Number | Percentage of Participants | From baseline up to 45 days |
|
|
|
| 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. | 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. | Posted | Number | Percentage of Participants | From baseline up to 45 days |
|
|
|
| 2 |
| 24 |
| 6 |
| 24 |
| 6 |
| 24 |
| Cardiac aneurysm | Cardiac disorders | MedDRA Version 19 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA Version 19 | Non-systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA Version 19 | Non-systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA Version 19 | Non-systematic Assessment |
|
| Device embolization | General disorders | MedDRA Version 19 | Non-systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA Version 19 | Non-systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA Version 19 | Non-systematic Assessment |
|
| Pneumococcal sepsis | Infections and infestations | MedDRA Version 19 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA Version 19 | Non-systematic Assessment |
|
| Arterial injury | Injury, poisoning and procedural complications | MedDRA Version 19 | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA Version 19 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA Version 19 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 19 | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Version 19 | Non-systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 19 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA Version 19 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA Version 19 | Non-systematic Assessment |
|
Results of this clinical study may be submitted for publication without regard for whether the trial results are positive or negative. Sponsor will be responsible for oversight of the publication process and will have oversight of publications of results of the trial, the Physician Advisory Committee may advise.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |