The Fourth Left Atrial Appendage Occlusion Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHamilton Health Sciences Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism
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).]
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.
Disqualifiers
Age < 18 years
Current left atrial appendage thrombus
Prior left atrial appendage occlusion or removal (surgical or percutaneous)
Prior percutaneous atrial septal defect or patent foramen ovale closure
Trial design
Design model
Parallel
Treatments tested in this trial
WATCHMAN device
DeviceParticipants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device
Treatment groups
4,000 Participants
are divided into 2 treatment groupsGroup A: WATCHMAN deviceExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
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 outcomes
1
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
Time frame
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).2
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)
Time frame
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).3
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
Time frame
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).4
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
Time frame
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 outcomes
1
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)
Time frame
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).2
Hospitalization for any cause
Time from randomization to first occurrence of hospitalization for any cause
Time frame
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).3
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
Time frame
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).4
Myocardial Infarction
Time from randomization to first occurrence of Myocardial Infarction (4th Universal definition)
Time frame
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hamilton Health Sciences Corporation
Lead sponsor
McMaster University
Collaborator
Population Health Research Institute
Collaborator
Boston Scientific Corporation
Collaborator
Source ClinicalTrials.gov