Atrial Fibrillation Clinical Trial
— LAAOS-4Official title:
The Fourth Left Atrial Appendage Occlusion Study (LAAOS-4)
LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.
Status | Recruiting |
Enrollment | 4000 |
Est. completion date | December 1, 2029 |
Est. primary completion date | September 1, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. (a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism 2. Increased risk of stroke, defined as a CHA2DS2-VASc stroke risk score of = 4. [Note: the acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age =75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female).] 3. Treatment with oral anticoagulants (Vitamin K agonist or factor Xa inhibitor) for at least 90 days prior to enrollment, AND no documented plan to discontinue treatment with oral anticoagulants for the expected duration of the trial. Exclusion Criteria: 1. Age < 18 years 2. Current left atrial appendage thrombus 3. Prior left atrial appendage occlusion or removal (surgical or percutaneous) 4. Prior percutaneous atrial septal defect or patent foramen ovale closure 5. Prior atrial fibrillation ablation unless evidence of recurrent qualifying atrial fibrillation present at least 30 days following ablation 6. Planned atrial fibrillation ablation within 90 days of enrollment 7. Individuals being treated with direct thrombin inhibitors 8. Women of childbearing potential unless they agree to employ effective birth control methods throughout the study 9. Anticipated life-expectancy of < 2 years 10. Patient unable or willing to give informed consent |
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton Health Sciences Corp | Hamilton | Ontario |
United States | Arrhythmia Research Group | Jonesboro | Arkansas |
Lead Sponsor | Collaborator |
---|---|
Hamilton Health Sciences Corporation | Boston Scientific Corporation, McMaster University, Population Health Research Institute |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Non-procedural Major Bleeding | Proportion of participants with non-procedural Major Bleeding (International Society on Thrombosis and Haemostasis (ISTH) definition; excluding WATCHMAN-related bleeding within 14 days of implant) | Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years). | |
Other | Hospitalization for any cause | Time from randomization to first occurrence of hospitalization for any cause | Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years). | |
Other | Heart failure hospitalization or emergency department/clinic visit for intensification of heart failure related therapy | Time from randomization to first occurrence of heart failure hospitalization or emergency department/clinic visit for intensification of heart failure related therapy | Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years). | |
Other | Myocardial Infarction | Time from randomization to first occurrence of Myocardial Infarction (4th Universal definition) | Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years). | |
Other | Device and procedural-related outcomes: Device-related thrombus | Proportion of participants with device-related thrombus (thrombus formed on the surface of the WATCHMAN device) | Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years). | |
Other | Device and procedural-related outcomes: Incomplete left atrial appendage (LAA) closure | Proportion of participants with incomplete LAA closure | Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years). | |
Other | Device and procedural-related outcomes: Peri-procedural major bleeding | Proportion of participants with peri-procedural major bleeding (ISTH definition; within 14 days following the procedure) | Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years). | |
Primary | Ischemic stroke or systemic embolism | The primary efficacy variable is the time from randomization to first occurrence of any of the components of the composite outcome (adjudicated) over the duration of follow-up, including:
Ischemic stroke (Strokes of undetermined etiology will be treated as ischemic stroke) Systemic embolism |
The study duration is event-driven. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years). | |
Secondary | All-cause stroke or systemic embolism | Secondary efficacy outcomes will be evaluated in a hierarchical fashion only when the primary outcome meets statistical significance in the specified order:
Time from randomization to first occurrence of all-cause stroke or systemic embolism |
Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years). | |
Secondary | All-cause stroke, systemic embolism, or transient ischemic attack (TIA) | Time from randomization to first occurrence of all-cause stroke, systemic embolism or transient ischemic attack (TIA) | Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years). | |
Secondary | Montreal Cognitive Assessment (MoCA) Score | Proportion of participants with a decrease of two or more points on the MoCA score at either year 2 or end of study | Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years). | |
Secondary | New disabling ischemic strokes | Time from randomization to first occurrence of disabling ischemic strokes with modified Rankin Score (mRS) >2, measured at 90 days post-stroke | Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years). | |
Secondary | Cardiovascular mortality | Time from randomization to cardiovascular mortality | Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years). | |
Secondary | All-cause mortality | Time from randomization to all-cause mortality | Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years). |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
Completed |
NCT04571385 -
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
|
Phase 2 | |
Completed |
NCT05366803 -
Women's Health Initiative Silent Atrial Fibrillation Recording Study
|
N/A | |
Completed |
NCT02864758 -
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
|
||
Recruiting |
NCT05442203 -
Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
|
N/A | |
Completed |
NCT05599308 -
Evaluation of Blood Pressure Monitor With AFib Screening Feature
|
N/A | |
Completed |
NCT03790917 -
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
|
||
Enrolling by invitation |
NCT05890274 -
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
|
N/A | |
Recruiting |
NCT05266144 -
Atrial Fibrillation Patients Treated With Catheter Ablation
|
||
Recruiting |
NCT05316870 -
Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation
|
N/A | |
Not yet recruiting |
NCT06023784 -
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
Completed |
NCT04087122 -
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
|
N/A | |
Completed |
NCT06283654 -
Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
|
||
Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|
||
Completed |
NCT04546763 -
Study Watch AF Detection At Home
|
||
Completed |
NCT03761394 -
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
|
N/A |