LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs

NCT06060912 | Recruiting DMC

• 1 other identifier: GE IDE No. T00322
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Atrial Appendage Occlusion

Keywords

Left Atrial Appendage Occlusion; Non-pharmacological anticoagulation therapy; Stroke prophylaxis

Outcome Measures

Primary Outcomes (1)

• PDL size after 3 months

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

  three months

Secondary Outcomes (13)

• Device Sucess

  at index prozedure

• Procedural Duration

  at index procedure

• Technical success

  during index hospitalization

• Procedural success

  at index procedure

• Device-related complications

  at three months

Study Arms (2)

LAmbre occlusion device

EXPERIMENTAL

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

Device: Left Atrial Appendage Occlusion

AMPLATZER Amulet occlusion device

ACTIVE COMPARATOR

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

Device: Left Atrial Appendage Occlusion

Interventions

Left Atrial Appendage Occlusion 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; LAmbre occlusion device

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Intracardiac thrombus
• Intracardiac tumor
• Existing, clinically relevant circumferential pericardial effusion
• Significant mitral valve stenosis

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• Lifetech Scientific (Shenzhen) Co., Ltd.: collaborator

Study Sites (1)

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

Munich, Bavaria, 80636, Germany

RECRUITING

Related Publications (15)

• 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.

  PMID: 17397680 BACKGROUND

• 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.

  PMID: 19683639 BACKGROUND

• 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.

  PMID: 21242484 BACKGROUND

• 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.

  PMID: 24998121 BACKGROUND

• 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.

  PMID: 29103847 BACKGROUND

• 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.

  PMID: 34459659 BACKGROUND

• 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.

  PMID: 29122133 BACKGROUND

• 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.

  PMID: 29885707 BACKGROUND

• 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.

  PMID: 30583991 BACKGROUND

• 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.

  PMID: 32072692 BACKGROUND

• 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.

  PMID: 21670242 BACKGROUND

• 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.

  PMID: 27540038 BACKGROUND

• 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.

  PMID: 19762550 BACKGROUND

• 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.

  PMID: 20299623 BACKGROUND

• 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.

  PMID: 31474583 BACKGROUND

MeSH Terms

Interventions

Left Atrial Appendage Closure

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Michael Joner, MD

  Klinik für Herz- und Kreilauferkankungen, Deutsches Herzzentrum München

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Joner, MD

CONTACT

+4989-1218-2869; joner@dhm.mhn.de

Tobias Rheude, MD

CONTACT

+4989-1218-2985; rheude@dhm.mhn.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: AMPIRI is an investigator-initiated, prospective, randomized, multicenter, open-label, non-inferiority other clinical investigation.

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 29, 2023
• Study Start: December 5, 2023
• Primary Completion: January 15, 2026
• Study Completion (Estimated): October 15, 2027
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)