Post-approval Study of Percutaneous Left Atrial Appendage Closure ( FLAAC-2 ) (FLAAC-2)

September 15, 2022 updated by: French Cardiology Society

Post-approval Study of Percutaneous Left Atrial Appendage Closure

Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to a stroke or systemic embolism. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is a new interventional cardiology technique for patients at high risk of stroke related to atrial fibrillation in whom long term anticoagulation therapy cannot be conducted. This procedure involves implantation of an occlusion device into the left atrial appendage to close it and prevent migration of thrombotic material that can cause distant embolism. Closure of the left atrial appendage avoids long term prescription of anticoagulants while protecting patients against the risk of systemic embolism and stroke. In 2016, two devices developed for transcutaneous closure of the left atrial appendage (WATCHMAN, Boston Scientific, AMPLATZER CARDIAC PLUG, S. Jude Medical and its evolution AMPLATZER AMULET) were included in the list of products reimbursable in France. The French national authorities have requested the realization of a register whose objectives will be to evaluate:

  • The efficiency and safety of implanting devices in France
  • The type and duration of antithrombotic treatment prescribed after left atrial appendage closure

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1051

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France
        • Henri Mondor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All French centers practicing percutaneous closure of the left atrial appendage will participate in the present study, whatever the technique used. The patients included in the protocol will be followed as part of the care by the centers that will have carried out the procedure.

Description

Inclusion Criteria:

Any patient for whom an indication has been made for implantation of a device for the closure of the left atrial appendage without restriction of indication and regardless of the outcome of the procedure (implantation success or not).ot).

Exclusion Criteria:

  • Refusal of the patient to participate in this study and therefore the use of his data
  • Minor patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Left atrial appendage closure

All patient referred to a department of interventional cardiology for percutaneous left atrial appendage closure may be included.

All centers practicing this procedure in France will participate to the present study, whatever the technique used. The patients included in the protocol will be followed as part of the care by centers that will have carried out the procedure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency of events at one year
Time Frame: 1 year
The primary efficacy endpoint is the frequency of a combined endpoint including ischemic strokes, systemic embolism, unexplained deaths, and cardiovascular death one year after left atrial appendage closure. This frequency will be expressed as the percentage of patients who presented at least one of these events. Only the first event occurring in each patient concerned will be taken into account, in the case where the same patient would present several events.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy at the end of the procedure
Time Frame: One hour after the end of the procedure
At the end of the procedure, the efficiency of the procedure will be described by the percentage of success of the procedure. The successful procedure is defined by a successful implantation of the device in the left atrial appendage without presaging its occlusive character.
One hour after the end of the procedure
Percentage of occlusion of the left atrial appendage objectified by transesophageal echography at 3 months of follow up
Time Frame: 3 months of follow up
Percentage of patients in whom the left atrial appendage is effectively closed,
3 months of follow up
Percentage of residual leakage revealed by transesophageal echocardiography at 3 months of follow up
Time Frame: 3 months of follow up
Percentage of patients with residual leakage
3 months of follow up
Percentage of ischemic stroke at 1 year of follow up
Time Frame: 1 year of follow up
Percentage of patients with at least one ischemic stroke between the procedure and the 1-year visit
1 year of follow up
Percentage of transient ischemic attack (TIA) at 1 year of follow up
Time Frame: 1 year of follow up
Percentage of patients presenting at least one TIA between the procedure and the 1-year visit
1 year of follow up
Percentage of systemic embolism at 1 year of follow up
Time Frame: 1 year of follow up
Percentage of patients with at least one systemic embolism between procedure and follow-up at 1 year
1 year of follow up
Percentage of cardiovascular or unexplained death at 1 year of follow up
Time Frame: 1 year of follow up
Percentage of patients who had a cardiovascular or unexplained death between the procedure and the 1-year follow-up
1 year of follow up
Mortality at 1 year of follow up
Time Frame: 1 year of follow up
Percentage of deaths between procedure and follow-up at 1 year
1 year of follow up
Frequency of cerebral or systemic ischemic events at 1 year of follow up
Time Frame: 1 year of follow up
Comparison of the frequency of cerebral or systemic ischemic events to the predicted theoretical value according to the CHA2DS2-VASc score of the population included
1 year of follow up
Rate of complications related or potentially related to the device or the implantation procedure after 7 days of follow up
Time Frame: 7 days of follow up or discharge (if later then D7)
Rate of complications related or potentially related to the device or the implantation procedure
7 days of follow up or discharge (if later then D7)
Percentage of pericardial effusion after 7 days of follow up
Time Frame: 7 days of follow up or discharge (if later then D7)
Percentage of patients who presented a pericardial effusion objectified by trans-thoracic ultrasound between the procedure and the discharge from hospital
7 days of follow up or discharge (if later then D7)
Percentage of migration of the device after 7 days of follow up
Time Frame: 7 days of follow up or discharge (if later then D7)
Percentage of patients who presented a migration of the device, objectified by the trans-thoracic ultrasound between the procedure and discharge
7 days of follow up or discharge (if later then D7)
Percentage of device thrombosis at 3 months of follow up
Time Frame: 3 months of follow up
Percentage of patients who presented thrombosis on the device, objectified by transesophageal echography and / or CT scan
3 months of follow up
Percentage of device migration at 3 months of follow up
Time Frame: 3 months of follow up
Percentage of patients who had a migration of the device, objectified by transesophageal echography and / or CT scan
3 months of follow up
Rate of complications related or potentially related to the device or procedure after 1 year of follow up
Time Frame: 1 year of follow up
Percentage of patients who had at least one device or procedure complication, such as tamponade requiring surgical drainage, device migration, residual leakage between procedure and 1 year follow-up
1 year of follow up
Device thrombosis or device migrations by trans-thoracic ultrasound after 1 year of follow up
Time Frame: 1 year of follow up
Percentage of device thrombosis or device migrations by trans-thoracic ultrasound
1 year of follow up
Clinical evolution of the patient at 1 year
Time Frame: 1 year of follow up
The percentage of life threatening, disabling or major hemorrhagic complications that occurred between the procedure and the 1-year follow-up will be recorded.
1 year of follow up
Criteria for Evaluating Associated Antithrombotic Treatments
Time Frame: 1 year of follow up

The antithrombotic treatments will be collected at patient's exit, and at 3, 6 and 12 months after implantation.

The type and duration of anti-thrombotic treatments will be documented using the combined criteria:

  • Percentage of patients on injectable or oral anticoagulants and antiplatelet agents at different follow-up times
  • Percentage of patients on injectable or oral anticoagulants at different follow-up times
  • The percentage of patients on platelet antiaggregants in single or dual therapy at different follow-up times
  • The average duration of anticoagulant and antiplatelet treatments
1 year of follow up
Description of the population and centers
Time Frame: At inclusion

Demographic and clinical characteristics of the patients will be collected and described, such as: age, sex, medical and surgical history, cardiovascular pharmacological treatments, comorbidities, indication of left atrial closure, HAS-BLED and CHA2DS2-VASc scores, anatomical features of the left atrial appendage at inclusion.

The type of health facility and the profile of the investigators will be evaluated according to:

  • The place of exercise of the investigators: percentage of physicians practicing in public centers, percentage of physicians practicing in hospital, percentage of physicians practicing in the private sector, percentage of physicians practicing in two sectors
  • The average number of implantations of each device made by the investigators since their first use of each system
At inclusion
Evaluation of implantation indications
Time Frame: At inclusion

The cause of left atrial appendage closure will also be evaluated by comparing the indications of implantation of the device with the indications retained by the CNEDIMTS, taking into account the following combined criteria:

  • CHA2DS2-VASc Score
  • Strict contraindication to anticoagulant therapy
  • Nonvalvular FA
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
French Cardiology Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Nicole NACCACHE, French Society of Cardio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 9, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 7, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3528-NI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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