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Atrial FibrillationFLAAC-2NCT03434015

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

An observational study of Atrial Fibrillation, run by French Cardiology Society at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
How many people
1,051 participants
Where
1 siteFrance
Study dates
9 Jul 2018to 7 Oct 2021
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: 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.

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Henri Mondor Hospital

    Créteil

Other trials in France

About this study

Official title: 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
Keywords
Atrial fibrillation, Left atrial septal closure
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03434015
Study groupRoleWhat they receive
Left atrial appendage closureAll 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of events at one 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.

    Measured: 1 year

Secondary outcomes (20)

  1. Efficacy at 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.

    Measured: One hour after the end of the procedure

  2. Percentage of occlusion of the left atrial appendage objectified by transesophageal echography at 3 months of follow up

    Percentage of patients in whom the left atrial appendage is effectively closed,

    Measured: 3 months of follow up

  3. Percentage of residual leakage revealed by transesophageal echocardiography at 3 months of follow up

    Percentage of patients with residual leakage

    Measured: 3 months of follow up

  4. Percentage of ischemic stroke at 1 year of follow up

    Percentage of patients with at least one ischemic stroke between the procedure and the 1-year visit

    Measured: 1 year of follow up

  5. Percentage of transient ischemic attack (TIA) at 1 year of follow up

    Percentage of patients presenting at least one TIA between the procedure and the 1-year visit

    Measured: 1 year of follow up

  6. Percentage of systemic embolism at 1 year of follow up

    Percentage of patients with at least one systemic embolism between procedure and follow-up at 1 year

    Measured: 1 year of follow up

  7. Percentage of cardiovascular or unexplained death at 1 year of follow up

    Percentage of patients who had a cardiovascular or unexplained death between the procedure and the 1-year follow-up

    Measured: 1 year of follow up

  8. Mortality at 1 year of follow up

    Percentage of deaths between procedure and follow-up at 1 year

    Measured: 1 year of follow up

  9. Frequency of cerebral or systemic ischemic events at 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

    Measured: 1 year of follow up

  10. Rate of complications related or potentially related to the device or the implantation procedure after 7 days of follow up

    Rate of complications related or potentially related to the device or the implantation procedure

    Measured: 7 days of follow up or discharge (if later then D7)

  11. Percentage of pericardial effusion after 7 days of follow up

    Percentage of patients who presented a pericardial effusion objectified by trans-thoracic ultrasound between the procedure and the discharge from hospital

    Measured: 7 days of follow up or discharge (if later then D7)

  12. Percentage of migration of the device after 7 days of follow up

    Percentage of patients who presented a migration of the device, objectified by the trans-thoracic ultrasound between the procedure and discharge

    Measured: 7 days of follow up or discharge (if later then D7)

  13. Percentage of device thrombosis at 3 months of follow up

    Percentage of patients who presented thrombosis on the device, objectified by transesophageal echography and / or CT scan

    Measured: 3 months of follow up

  14. Percentage of device migration at 3 months of follow up

    Percentage of patients who had a migration of the device, objectified by transesophageal echography and / or CT scan

    Measured: 3 months of follow up

  15. Rate of complications related or potentially related to the device or procedure after 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

    Measured: 1 year of follow up

  16. Device thrombosis or device migrations by trans-thoracic ultrasound after 1 year of follow up

    Percentage of device thrombosis or device migrations by trans-thoracic ultrasound

    Measured: 1 year of follow up

  17. Clinical evolution of the patient at 1 year

    The percentage of life threatening, disabling or major hemorrhagic complications that occurred between the procedure and the 1-year follow-up will be recorded.

    Measured: 1 year of follow up

  18. Criteria for Evaluating Associated Antithrombotic Treatments

    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

    Measured: 1 year of follow up

  19. Description of the population and centers

    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

    Measured: At inclusion

  20. Evaluation of implantation indications

    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

    Measured: At inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2018
  2. Study start9 Jul 2018
  3. Primary completion15 Feb 2020
  4. Study completion7 Oct 2021

Resources

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
1,051 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03434015
Sponsor's protocol ID
3528-NI
Acronym
FLAAC-2
Status last verified
Sep 2022
First submitted
25 Jan 2018
Last updated
16 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Menke J, Luthje L, Kastrup A, Larsen J. Thromboembolism in atrial fibrillation. Am J Cardiol. 2010 Feb 15;105(4):502-10. doi: 10.1016/j.amjcard.2009.10.018.

    PubMed 20152245

  • Feinberg WM, Blackshear JL, Laupacis A, Kronmal R, Hart RG. Prevalence, age distribution, and gender of patients with atrial fibrillation. Analysis and implications. Arch Intern Med. 1995 Mar 13;155(5):469-73.

    PubMed 7864703

  • Heeringa J, van der Kuip DA, Hofman A, Kors JA, van Herpen G, Stricker BH, Stijnen T, Lip GY, Witteman JC. Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study. Eur Heart J. 2006 Apr;27(8):949-53. doi: 10.1093/eurheartj/ehi825. Epub 2006 Mar 9.

    PubMed 16527828

  • Knecht S, Wilton SB, Haissaguerre M. The 2010 update of the ESC guidelines for the management of atrial fibrillation. Circ J. 2010 Nov;74(12):2534-7. doi: 10.1253/circj.cj-10-1030. Epub 2010 Nov 2. No abstract available.

    PubMed 21060205

  • Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996 Feb;61(2):755-9. doi: 10.1016/0003-4975(95)00887-X.

    PubMed 8572814

  • Lam YY, Yip GW, Yu CM, Chan WW, Cheng BC, Yan BP, Clugston R, Yong G, Gattorna T, Paul V. Left atrial appendage closure with AMPLATZER cardiac plug for stroke prevention in atrial fibrillation: initial Asia-Pacific experience. Catheter Cardiovasc Interv. 2012 Apr 1;79(5):794-800. doi: 10.1002/ccd.23136. Epub 2011 Nov 30.

    PubMed 21542102

  • Dawson AG, Asopa S, Dunning J. Should patients undergoing cardiac surgery with atrial fibrillation have left atrial appendage exclusion? Interact Cardiovasc Thorac Surg. 2010 Feb;10(2):306-11. doi: 10.1510/icvts.2009.227991. Epub 2009 Nov 26.

    PubMed 19942634

  • Sievert H, Lesh MD, Trepels T, Omran H, Bartorelli A, Della Bella P, Nakai T, Reisman M, DiMario C, Block P, Kramer P, Fleschenberg D, Krumsdorf U, Scherer D. Percutaneous left atrial appendage transcatheter occlusion to prevent stroke in high-risk patients with atrial fibrillation: early clinical experience. Circulation. 2002 Apr 23;105(16):1887-9. doi: 10.1161/01.cir.0000015698.54752.6d.

    PubMed 11997272

  • Klug D, Commeau P, Defaye P, Thambo JB, Gras D, Aubry P, Pasquie JL, Guerin P, Teiger E, Koning R, Piot O; Heart Rhythm, Pacing Group, the Atheroma, Interventional Cardiology Group of the French Society of Cardiology. Percutaneous occlusion of the left atrial appendage: An expert consensus statement. Arch Cardiovasc Dis. 2015 Aug-Sep;108(8-9):460-7. doi: 10.1016/j.acvd.2015.02.001.

    PubMed 26645055

  • Park JW, Bethencourt A, Sievert H, Santoro G, Meier B, Walsh K, Lopez-Minguez JR, Meerkin D, Valdes M, Ormerod O, Leithauser B. Left atrial appendage closure with Amplatzer cardiac plug in atrial fibrillation: initial European experience. Catheter Cardiovasc Interv. 2011 Apr 1;77(5):700-6. doi: 10.1002/ccd.22764. Epub 2011 Mar 8.

    PubMed 20824765

  • Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192.

    PubMed 25399274

  • Belgaid DR, Khan Z, Zaidi M, Hobbs A. Prospective randomized evaluation of the watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: The PREVAIL trial. Int J Cardiol. 2016 Sep 15;219:177-9. doi: 10.1016/j.ijcard.2016.06.041. Epub 2016 Jun 15.

    PubMed 27343417

  • Boersma LV, Schmidt B, Betts TR, Sievert H, Tamburino C, Teiger E, Pokushalov E, Kische S, Schmitz T, Stein KM, Bergmann MW; EWOLUTION investigators. Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry. Eur Heart J. 2016 Aug;37(31):2465-74. doi: 10.1093/eurheartj/ehv730. Epub 2016 Jan 27.

    PubMed 26822918

  • Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P; PROTECT AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009 Aug 15;374(9689):534-42. doi: 10.1016/S0140-6736(09)61343-X.

    PubMed 19683639

  • Reddy VY, Mobius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013 Jun 25;61(25):2551-6. doi: 10.1016/j.jacc.2013.03.035. Epub 2013 Apr 10.

    PubMed 23583249

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by French Cardiology Society at 1 site in France.

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 1 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: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Frequency of events at one year (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03434015, which also lists 21 linked publications.

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 16 Sep 2022.

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FLAAC-2 Clinical Trial NCT03434015 | AzTrials