Heart FailureLAAOSIIIXNCT05399342
Left Atrial Appendage Occlusion Study III Extended Follow Up
An observational study of Heart Failure and Left Atrial Appendage Occlusion, run by Population Health Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Left Atrial Appendage Occlusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Oct 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort of participants of the Left Atrial Appendage Occlusion III trial (ClinicalTrials.gov ID: NCT01561651)
Who may be able to join
- Participant was enrolled in the LAAOS III trial
- Participant has provided written informed consent
Who cannot join
- Participant did not undergo the index LAAOS III cardiac surgery
- Participant underwent heart transplant
About this study
Official title: Left Atrial Appendage Occlusion III Extended Follow Up
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.
Read the 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.
- Conditions
- Heart Failure, Left Atrial Appendage Occlusion
- Being tested
- No Intervention
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
The primary objective is to determine the impact of left atrial appendage (LAA) occlusion on all-cause mortality
Measured: 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
To examine the impact of LAA occlusion on the incidence of ischemic stroke or non-cerebral systemic embolism
Measured: Mean follow up of 8 years after LAAOS III cardiac surgery
Impact of LAA occlusion on re-hospitalization for heart failure
Impact of LAA occlusion on re-hospitalization for heart failure
Measured: Mean follow up of 8 years after LAAOS III cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Why it stopped: Did not receive grant funding to conduct the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Whitlock, Principal investigator, Population Health Research InstituteEmilie Belley-Côté, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399342
- Sponsor's protocol ID
- LAAOSIII Extension
- Acronym
- LAAOSIIIX
- Status last verified
- Oct 2022
- First submitted
- 26 May 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Appendage Occlusion III Extended Follow Up
- ClinicalTrials.gov ID
- NCT05399342
- Acronym / sponsor ID
- LAAOSIIIX / LAAOSIII Extension
- Conditions
- Heart Failure, Left Atrial Appendage Occlusion
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Did not receive grant funding to conduct the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAAOS III Extended Follow-Up Cohort | – | Other: No InterventionPatients randomized into the LAAOS III trial who have consented to longer term observational follow-up. There is no intervention in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of participants of the Left Atrial Appendage Occlusion III trial (ClinicalTrials.gov ID: NCT01561651)
Key inclusion criteria (2 listed)
- Participant was enrolled in the LAAOS III trial
- Participant has provided written informed consent
Key exclusion criteria (2 listed)
- Participant did not undergo the index LAAOS III cardiac surgery
- Participant underwent heart transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionPatients 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. | Other | LAAOS III Extended Follow-Up Cohort |
Primary outcome
All cause mortality
Time frame: Mean follow up of 8 years after LAAOS III cardiac surgery
The primary objective is to determine the impact of left atrial appendage (LAA) occlusion on all-cause mortality
2 secondary outcomes
Impact of LAA occlusion on the incidence of ischemic stroke or or non-cerebral systemic embolism
Time frame: Mean follow up of 8 years after LAAOS III cardiac surgery
Impact of LAA occlusion on re-hospitalization for heart failure
Time frame: Mean follow up of 8 years after LAAOS III cardiac surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Whitlock principal investigator
Population Health Research Institute
Emilie Belley-Côté principal investigator
Population Health Research Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Left Atrial Appendage Occlusion, run by Population Health Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: Mean follow up of 8 years after LAAOS III cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022; AzTrials last refreshed its copy on 1 Nov 2026.