NCT05399342

Brief Summary

LAAOS III Extension is a longer term follow-up of an international cohort study of patients who were enrolled in the Left Atrial Appendage Occlusion Study (LAAOS III) trial.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
17mo left

Started Jul 2022

Longer than P75 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jul 2022Oct 2027

First Submitted

Initial submission to the registry

May 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

November 3, 2022

Status Verified

October 1, 2022

Enrollment Period

3.9 years

First QC Date

May 26, 2022

Last Update Submit

October 31, 2022

Conditions

Heart FailureLeft Atrial Appendage Occlusion

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    The primary objective is to determine the impact of left atrial appendage (LAA) occlusion on all-cause mortality

    Mean follow up of 8 years after LAAOS III cardiac surgery

Secondary Outcomes (2)

  • Impact of LAA occlusion on the incidence of ischemic stroke or or non-cerebral systemic embolism

    Mean follow up of 8 years after LAAOS III cardiac surgery

  • Impact of LAA occlusion on re-hospitalization for heart failure

    Mean follow up of 8 years after LAAOS III cardiac surgery

Study Arms (1)

LAAOS III Extended Follow-Up Cohort

Patients randomized into the LAAOS III trial who have consented to longer term observational follow-up. There is no intervention in this study.

Other: No Intervention

Interventions

No InterventionOTHER

Patients in the LAAOS III trial either had or did not have their left atrial appendage occluded at the time of surgery in that trial. No further intervention is required in this cohort, it is observational follow-up only.

LAAOS III Extended Follow-Up Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cohort of participants of the Left Atrial Appendage Occlusion III trial (ClinicalTrials.gov ID: NCT01561651)

You may qualify if:

  • Participant was enrolled in the LAAOS III trial
  • Participant has provided written informed consent

You may not qualify if:

  • Participant did not undergo the index LAAOS III cardiac surgery
  • Participant underwent heart transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Richard Whitlock

    Population Health Research Institute

    PRINCIPAL INVESTIGATOR

  • Emilie Belley-Côté

    Population Health Research Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 1, 2022

Study Start

July 1, 2022

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

November 3, 2022

Record last verified: 2022-10