Clinical trial NCT05399342: Left Atrial Appendage Occlusion Study III Extended Follow Up
Official title: Left Atrial Appendage Occlusion III Extended Follow Up
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Failure
Left Atrial Appendage Occlusion
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of participants of the Left Atrial Appendage Occlusion III trial (ClinicalTrials.gov ID: NCT01561651)

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.

Detailed description: The association between atrial fibrillation and heart failure has been well established. Although the causal relationship between the two clinical entities has not been fully elucidated, atrial fibrillation is believed to cause heart failure via several mechanisms: 1) increased heart rate resulting in shorter diastolic filling time and lower cardiac output; 2) reduced atrial contraction contribution to left ventricular filling, lowering cardiac output; and 3) tachycardia-induced cardiomyopathy from myocardial ischemia, myocardial energy depletion, and abnormal calcium regulation leading to left ventricular dilatation and reduced ejection fraction. These processes occur over time. It is also established that the left atrial appendage is a source of atrial natriuretic peptide, and it has been hypothesized that removal of the appendage might impair renal clearance of salt and water, increasing the risk of heart failure. A recent non-randomized study has supported this hypothesis. In LAAOS III, we did not observe an increase in hospitalization for heart failure, either early after surgery or during the 3.8 years of follow-up. However, an adverse impact on heart failure may appear over a longer follow-up period. We need to ensure we examine this patient population for the long-term impact of left atrial appendage occlusion on heart failure hospitalization to ensure we fully appreciate the benefit-risk balance of this intervention.

The extended follow-up of the LAAOS III trial aims to assess whether, in patients with a history of atrial fibrillation undergoing cardiac surgery for another indication, concomitant left atrial appendage occlusion decreases the risk of death and stroke on top of usual care including anticoagulation without increasing re-hospitalization for heart failure at a mean follow-up of 8 years.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: All cause mortality
timeFrame: Mean follow up of 8 years after LAAOS III cardiac surgery
Secondary outcomes:
measure: Impact of LAA occlusion on the incidence of ischemic stroke or or non-cerebral systemic embolism
timeFrame: Mean follow up of 8 years after LAAOS III cardiac surgery
measure: Impact of LAA occlusion on re-hospitalization for heart failure
timeFrame: Mean follow up of 8 years after LAAOS III cardiac surgery
Other outcomes:
Locations:
Study officials:
affiliation: Population Health Research Institute
name: Richard Whitlock
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute
name: Emilie Belley-Côté
role: PRINCIPAL_INVESTIGATOR
References: