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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05963698
Other study ID # LAAOS-4
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 30, 2023
Est. completion date December 1, 2029

Study information

Verified date December 2023
Source Hamilton Health Sciences Corporation
Contact Program Director
Phone 905-521-2100
Email LAAOS-4@phri.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

LAAOS-4 is a multicentre, prospective, open-label, randomized controlled trial with blinded assessment of endpoints (PROBE) 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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
WATCHMAN device
Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device

Locations

Country Name City State
Canada Hamilton Health Sciences Corp Hamilton Ontario
United States Arrhythmia Research Group Jonesboro Arkansas

Sponsors (4)

Lead Sponsor Collaborator
Hamilton Health Sciences Corporation Boston Scientific Corporation, McMaster University, Population Health Research Institute

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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).
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