LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs (AMPIRI)

January 7, 2024 updated by: Deutsches Herzzentrum Muenchen

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

226

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80636
        • Recruiting
        • Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Indication for long-term oral anticoagulation therapy for a condition other than AF (i. e. pulmonary embolism, mechanical heart valve)
  2. LAA is obliterated or surgically ligated
  3. Known allergy or hypersensitivity to any component of the LAAO devices or components of the required medication regimen
  4. Prior atrial septal defect (ASD) repair or implantation of ASD closure device
  5. Active endocarditis or other infection producing bacteremia
  6. Significant symptomatic carotid artery disease
  7. Participation in a concurrent clinical trial, which may confound the results of this trial

  8. Patient cannot adhere to or complete the trial protocol for any reason

    Or any of the following echocardiographic exclusion criteria:

  9. Intracardiac thrombus
  10. Intracardiac tumor
  11. Existing, clinically relevant circumferential pericardial effusion
  12. Significant mitral valve stenosis

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LAmbre occlusion device
Left atrial occlusion will be performed with the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China)
Device: Left Atrial Appendage Occlusion
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.
Active Comparator: AMPLATZER Amulet occlusion device
Left atrial occlusion will be performed with AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA)
Device: Left Atrial Appendage Occlusion
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PDL size after 3 months
Time Frame: three months
Peri-device leak size (in mm) three months after successful LAAO as assessed with TOE.
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Sucess
Time Frame: at index prozedure
Defined as device deployed and implanted in correct position.
at index prozedure
Procedural Duration
Time Frame: at index procedure
End time (closing of X-Ray) minus start time (access site puncture).
at index procedure
Technical success
Time Frame: during index hospitalization
Defined as exclusion of the LAA with residual peri device leak size ≤ 5mm and no device-related complications during index hospitalization.
during index hospitalization
Procedural success
Time Frame: at index procedure
defined as technical success with no procedure-related complications, except for uncomplicated (minor) device embolization
at index procedure
Device-related complications
Time Frame: at three months
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)
at three months
Procedure-related complications
Time Frame: during index hospitalization
Pericardial effusion with or without tamponade requiring pericardiocentesis or surgical intervention.
during index hospitalization
Major bleeding
Time Frame: during index hospitalization
Defined as Bleeding Academic Research Consortium (BARC) type ≥ 3.
during index hospitalization
Large residual peri-device leak size > 5mm
Time Frame: at three months
Large peri device leak size (in mm) >5 mm three months after successful LAAO as assessed with TOE.
at three months
Device thrombus
Time Frame: at three months
Device thrombus at three months after successful LAAO as assessed with TOE.
at three months
All-cause death or cardiovascular death
Time Frame: during index hospitalization and up to 24 months

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).
during index hospitalization and up to 24 months
Composite of ischaemic stroke or systemic embolism
Time Frame: during index hospitalization and up to 24 months
Incidence of ischaemic stroke or systemic embolism, as described below.
during index hospitalization and up to 24 months
All-stroke
Time Frame: during index hospitalization and up to 24 months
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.
during index hospitalization and up to 24 months
Systemic embolism
Time Frame: during index hospitalization and up to 24 months
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.
during index hospitalization and up to 24 months

Collaborators and Investigators

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

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

Lifetech Scientific (Shenzhen) Co., Ltd.

Investigators

  • Principal Investigator: Michael Joner, MD, Klinik für Herz- und Kreilauferkankungen, Deutsches Herzzentrum München

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)

December 5, 2023

Primary Completion (Estimated)

January 15, 2026

Study Completion (Estimated)

October 15, 2027

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE No. T00322

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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