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Left Atrial Appendage OcclusionAMPIRINCT06060912

LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs

A study testing Left Atrial Appendage Occlusion in people with Left Atrial Appendage Occlusion, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The objective of this trial is to compare two different commercially available left atrial appendage occlusion (LAAO) devices in patients with non-valvular Atrial fibrillation/ atrial flutter (AF) at increased risk for stroke with regard to safety and efficacy. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Left Atrial Appendage Occlusion
What is being tested?
Left Atrial Appendage Occlusion
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
1 siteGermany
Study dates
5 Dec 2023to 15 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years and able to give consent
  • Documented paroxysmal, persistent or permanent non-valvular atrial fibrillation/ atrial flutter (AF) at high risk of stroke or systemic embolism defined by CHA2DS2-VASc score ≥ 2 (male) or ≥ 3 (female)
  • Patient not eligible for long-term oral anticoagulation therapy
  • Deemed suitable for percutaneous LAAO
  • Able to comply with the required medication regimen after LAAO device implantation
  • Written informed consent
  • LAA anatomy can accommodate either a LAmbre or AMPLATZER Amulet LAAO device, as per manufacturer's instruction for use (IFU) (the anatomy and sizing must be appropriate for both devices in order to be enrolled in the trial)
  • For women of childbearing potential, negative pregnancy test and agree to use reliable method of birth control during the study

Who cannot join

  • Indication for long-term oral anticoagulation therapy for a condition other than AF (i. e. pulmonary embolism, mechanical heart valve)
  • LAA is obliterated or surgically ligated
  • Known allergy or hypersensitivity to any component of the LAAO devices or components of the required medication regimen
  • Prior atrial septal defect (ASD) repair or implantation of ASD closure device
  • Active endocarditis or other infection producing bacteremia
  • Significant symptomatic carotid artery disease
Show all 13Show fewer
  • Participation in a concurrent clinical trial, which may confound the results of this trial
  • Patient cannot adhere to or complete the trial protocol for any reason
  • Or any of the following echocardiographic exclusion criteria:
  • Intracardiac thrombus
  • Intracardiac tumor
  • Existing, clinically relevant circumferential pericardial effusion
  • Significant mitral valve stenosis

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michael Joner, MD contact

+4989-1218-2869

joner@dhm.mhn.de

Tobias Rheude, MD contact

+4989-1218-2985

rheude@dhm.mhn.de

Germany1 site, 1 recruiting

  • Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München

    Munich, Bavaria, 80636

    Tobias Rheude, MD, +49 89 1218 2985, rheude@dhm.mhn.de

    Recruiting

Other trials in Germany

About this study

Official title: LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs: The Randomized AMPIRI Trial

The objective of this trial is to compare two different commercially available left atrial appendage occlusion (LAAO) devices in patients with non-valvular Atrial fibrillation/ atrial flutter (AF) at increased risk for stroke with regard to safety and efficacy.

The investigators hypothesize that LAAO using the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China) is non-inferior to LAAO using the AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA) with regards to the primary endpoint, which is peri-device leak (PDL) size 3 months after LAAO, as assessed with transesophageal echocardiography (TOE) in patients with non-valvular AF.

Read the detailed description

AMPIRI is an investigator-initiated, prospective, randomized, multi-center, open-label, non-inferiority other clinical investigation. All consecutive patients with non-valvular AF at increased risk for stroke or systemic embolism based on CHA2DS2-VASc score not eligible for long-term oral anticoagulation therapy will qualify for screening. Patients with confirmed eligibility and who have given written informed consent will be randomized in a 1:1 fashion to group A (LAmbre LAAO device) or group B (AMPLATZER Amulet LAAO device). Clinical indication, technique, and timing of LAAO will be at the operator's discretion.

The investigators hypothesize that LAAO using the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China) is non-inferior to LAAO using the AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA) with regards to the primary endpoint, which is PDL size 3 months after LAAO, as assessed with TOE in patients with non-valvular AF.

Being tested
Left Atrial Appendage Occlusion
Keywords
Left Atrial Appendage Occlusion, Non-pharmacological anticoagulation therapy, Stroke prophylaxis

What participants receive

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

  • Left Atrial Appendage OcclusionDevice

    Left Atrial Appendage Occlusion will be performed according to current international standards by experienced operators under TOE and angiographic guidance. Either a LAmbre occlusion device (group A) or an AMPLATZER Amulet occlusion device (group B) will be implanted depending on treatment allocation.

Study groups in NCT06060912
Study groupRoleWhat they receive
LAmbre occlusion deviceExperimentalLeft atrial occlusion will be performed with the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China)
Receives: Device: Left Atrial Appendage Occlusion
AMPLATZER Amulet occlusion deviceActive comparatorLeft atrial occlusion will be performed with AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA)
Receives: Device: Left Atrial Appendage Occlusion

What is being measured

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

  1. PDL size after 3 months

    Peri-device leak size (in mm) three months after successful LAAO as assessed with TOE.

    Measured: three months

Secondary outcomes (13)

  1. Device Sucess

    Defined as device deployed and implanted in correct position.

    Measured: at index prozedure

  2. Procedural Duration

    End time (closing of X-Ray) minus start time (access site puncture).

    Measured: at index procedure

  3. Technical success

    Defined as exclusion of the LAA with residual peri device leak size ≤ 5mm and no device-related complications during index hospitalization.

    Measured: during index hospitalization

  4. Procedural success

    defined as technical success with no procedure-related complications, except for uncomplicated (minor) device embolization

    Measured: at index procedure

  5. Device-related complications

    All complications which are a result of the presence of the device and require either a surgical or percutaneous intervention or other medical treatment (device embolization, device erosion, clinically significant device interference with surrounding structure, device thrombus, device fracture, device infection/pericarditis, endocarditis, device perforation/laceration or device allergy)

    Measured: at three months

  6. Procedure-related complications

    Pericardial effusion with or without tamponade requiring pericardiocentesis or surgical intervention.

    Measured: during index hospitalization

  7. Major bleeding

    Defined as Bleeding Academic Research Consortium (BARC) type ≥ 3.

    Measured: during index hospitalization

  8. Large residual peri-device leak size > 5mm

    Large peri device leak size (in mm) >5 mm three months after successful LAAO as assessed with TOE.

    Measured: at three months

  9. Device thrombus

    Device thrombus at three months after successful LAAO as assessed with TOE.

    Measured: at three months

  10. All-cause death or cardiovascular death

    Cardiovascular Death:

    • Death due to proximate cardiac cause, e.g. myocardial infarction, cardiac tamponade, worsening heart failure, and endocarditis.
    • Death caused by non-coronary, non-CNS vascular conditions such as pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease.
    • Death from vascular CNS causes from haemorrhagic stroke or from ischaemic stroke.
    • All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure.
    • Sudden or unwitnessed death defined as non-traumatic, unexpected fatal event occurring within 1 hour of the onset of symptoms in an apparently healthy subject. If death is not witnessed, the definition applies when the victim was in good health 24 hours before the event.
    • Death of unknown cause:

    Non-cardiovascular death: Death of a primary cause that is clearly related to another condition (e.g. trauma, cancer, suicide).

    Measured: during index hospitalization and up to 24 months

  11. Composite of ischaemic stroke or systemic embolism

    Incidence of ischaemic stroke or systemic embolism, as described below.

    Measured: during index hospitalization and up to 24 months

  12. All-stroke

    Defined as an acute episode of focal or global neurological deficit with at least one of the following: change in the level of consciousness, hemiplegia, hemiparesis, one-sided numbness or sensory loss, dysphasia or aphasia, hemianopia, amaurosis fugax or any other neurological signs or symptoms consistent with stroke. It is caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. A transient ischemic attack (TIA) should be clearly distinguished from ischemic stroke, based on focal neurological symptoms lasting <24 hours and imaging-confirmed absence of acute brain infarction. Therefore, it is mandatory to recommend imaging confirmation as part of the diagnosis. Stroke assessment requires a neuroimaging and neurological examination, preferably by a neurologist.

    Measured: during index hospitalization and up to 24 months

  13. Systemic embolism

    Systemic embolism: Acute vascular insufficiency or occlusion of the extremities or any non-central nervous system organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (e.g., trauma, atherosclerosis, or instrumentation). When there is presence of prior peripheral artery disease, angiographic or surgical or autopsy evidence is required to show abrupt arterial occlusion.

    Measured: during index hospitalization and up to 24 months

Timeline

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

  1. First posted29 Sep 2023
  2. Study start5 Dec 2023
  3. Primary completion15 Jan 2026 (estimated)
  4. Study completion15 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
AMPIRI is an investigator-initiated, prospective, randomized, multicenter, open-label, non-inferiority other clinical investigation.
Masking
None (open label)
Enrolment
226 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06060912
Sponsor's protocol ID
GE IDE No. T00322
Acronym
AMPIRI
Status last verified
Jan 2024
First submitted
11 Sep 2023
Last updated
9 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sick PB, Schuler G, Hauptmann KE, Grube E, Yakubov S, Turi ZG, Mishkel G, Almany S, Holmes DR. Initial worldwide experience with the WATCHMAN left atrial appendage system for stroke prevention in atrial fibrillation. J Am Coll Cardiol. 2007 Apr 3;49(13):1490-5. doi: 10.1016/j.jacc.2007.02.035. Epub 2007 Mar 21.

    PubMed 17397680

  • 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, Holmes D, Doshi SK, Neuzil P, Kar S. Safety of percutaneous left atrial appendage closure: results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry. Circulation. 2011 Feb 1;123(4):417-24. doi: 10.1161/CIRCULATIONAHA.110.976449. Epub 2011 Jan 17.

    PubMed 21242484

  • Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014 Jul 8;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029.

    PubMed 24998121

  • Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. doi: 10.1016/j.jacc.2017.10.021. Epub 2017 Nov 4.

    PubMed 29103847

  • Lakkireddy D, Thaler D, Ellis CR, Swarup V, Sondergaard L, Carroll J, Gold MR, Hermiller J, Diener HC, Schmidt B, MacDonald L, Mansour M, Maini B, O'Brien L, Windecker S. Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial. Circulation. 2021 Nov 9;144(19):1543-1552. doi: 10.1161/CIRCULATIONAHA.121.057063. Epub 2021 Aug 30.

    PubMed 34459659

  • Huang H, Liu Y, Xu Y, Wang Z, Li Y, Cao K, Zhang S, Yang Y, Yang X, Huang D, Yu B, Su X, Wu L, Huang C. Percutaneous Left Atrial Appendage Closure With the LAmbre Device for Stroke Prevention in Atrial Fibrillation: A Prospective, Multicenter Clinical Study. JACC Cardiovasc Interv. 2017 Nov 13;10(21):2188-2194. doi: 10.1016/j.jcin.2017.06.072.

    PubMed 29122133

  • Park JW, Sievert H, Kleinecke C, Vaskelyte L, Schnupp S, Sievert K, Lam YY, Stahli BE, Zhang D, Li A, Brachmann J. Left atrial appendage occlusion with lambre in atrial fibrillation: Initial European experience. Int J Cardiol. 2018 Aug 15;265:97-102. doi: 10.1016/j.ijcard.2018.02.120.

    PubMed 29885707

  • Chen S, Chun KRJ, Bordignon S, Weise FK, Nagase T, Perrotta L, Bologna F, Schmidt B. Left atrial appendage occlusion using LAmbre Amulet and Watchman in atrial fibrillation. J Cardiol. 2019 Apr;73(4):299-306. doi: 10.1016/j.jjcc.2018.10.010. Epub 2018 Dec 21.

    PubMed 30583991

  • Schnupp S, Liu XX, Buffle E, Gloekler S, Mohrez Y, Cheikh-Ibrahim M, Allakkis W, Brachmann J, Park JW, Kleinecke C. Late clinical outcomes of lambre versus amplatzer occluders for left atrial appendage closure. J Cardiovasc Electrophysiol. 2020 Apr;31(4):934-942. doi: 10.1111/jce.14398. Epub 2020 Mar 12.

    PubMed 32072692

  • Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

    PubMed 21670242

  • Tzikas A, Holmes DR Jr, Gafoor S, Ruiz CE, Blomstrom-Lundqvist C, Diener HC, Cappato R, Kar S, Lee RJ, Byrne RA, Ibrahim R, Lakkireddy D, Soliman OI, Nabauer M, Schneider S, Brachmann J, Saver JL, Tiemann K, Sievert H, Camm AJ, Lewalter T. Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies. Europace. 2017 Jan;19(1):4-15. doi: 10.1093/europace/euw141. Epub 2016 Aug 18.

    PubMed 27540038

  • Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest. 2010 Feb;137(2):263-72. doi: 10.1378/chest.09-1584. Epub 2009 Sep 17.

    PubMed 19762550

  • Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010 Nov;138(5):1093-100. doi: 10.1378/chest.10-0134. Epub 2010 Mar 18.

    PubMed 20299623

  • Glikson M, Wolff R, Hindricks G, Mandrola J, Camm AJ, Lip GYH, Fauchier L, Betts TR, Lewalter T, Saw J, Tzikas A, Sternik L, Nietlispach F, Berti S, Sievert H, Bertog S, Meier B. EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion - an update. EuroIntervention. 2020 Jan 17;15(13):1133-1180. doi: 10.4244/EIJY19M08_01. No abstract available.

    PubMed 31474583

Questions about this trial

What is this clinical trial studying?

A study testing Left Atrial Appendage Occlusion in people with Left Atrial Appendage Occlusion, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.

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 8 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 9 Jan 2024. 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 Germany. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michael Joner, MD (+4989-1218-2869, joner@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PDL size after 3 months (time frame: three months). 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 NCT06060912, which also lists 15 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 9 Jan 2024.

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