LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs

NCT ID: NCT06060912

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-05
• Study Completion Date: 2027-10-15

Brief 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.

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.

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.

Conditions

Left Atrial Appendage Occlusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LAmbre occlusion device

Left atrial occlusion will be performed with the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China)

Group Type: EXPERIMENTAL

Left Atrial Appendage Occlusion

Intervention Type: DEVICE

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.

AMPLATZER Amulet occlusion device

Left atrial occlusion will be performed with AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA)

Group Type: ACTIVE_COMPARATOR

Left Atrial Appendage Occlusion

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

9. Intracardiac thrombus

10. Intracardiac tumor

11. Existing, clinically relevant circumferential pericardial effusion

12. Significant mitral valve stenosis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lifetech Scientific (Shenzhen) Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Joner, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik für Herz- und Kreilauferkankungen, Deutsches Herzzentrum München

Locations

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

Munich, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Michael Joner, MD

Role: CONTACT

joner@dhm.mhn.de

+4989-1218-2869

Tobias Rheude, MD

Role: CONTACT

rheude@dhm.mhn.de

+4989-1218-2985

Facility Contacts

Tobias Rheude, MD

Role: primary

rheude@dhm.mhn.de

+49 89 1218 2985

References

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.

Reference Type: BACKGROUND

PMID: 17397680 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19683639 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21242484 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24998121 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29103847 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34459659 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29122133 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29885707 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30583991 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32072692 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21670242 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27540038 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19762550 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20299623 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31474583 (View on PubMed)

Other Identifiers

GE IDE No. T00322

Identifier Type: -

Identifier Source: org_study_id