Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure. (SWISS-APERO)

NCT ID: NCT03399851

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2026-05-31

Brief Summary

Left atrial appendage closure (LAAC) is an emerging therapeutic option in non-valvular atrial fibrillation (NVAF) patients with high thromboembolic and bleeding risks. In Europe the devices most frequently utilized for LAAC are Amplatzer Amulet (St. Jude Medical-Abbott) and Watchman (Boston Scientific) system. However there are currently no randomized controlled trials assessing the degree of LAA closure between the two devices. The main purpose of this trial is to evaluate the feasibility and the efficacy of the devices in terms of LAA complete occlusion with a non-invasive imaging technique such as cardiac computed tomography angiography (CCTA).

Detailed Description

Non-valvular Atrial fibrillation (NVAF) is the most common cardiac arrhythmia and a major cause of morbidity and mortality because of cardioembolic stroke. Oral anticoagulation (OAC) with vitamin K antagonists (VKA) or Non-vitamin K antagonist anticoagulant (NOAC) is the most effective prophylaxis for stroke in NVAF. However (N)OAC therapy is associated with a significant bleeding liability and long-term (N)OAC therapy in patients with NVAF and concomitant high bleeding risk poses safety issues in a sizable and growing population in clinical practice. Thus, a new and emerging therapeutic option in this high-risk patient population is the left atrial appendage closure (LAAC). There are many available systems approved for percutaneous LAAC. One of the most widely used is the Watchman™ system (Boston Scientific), which was tested in the setting of two randomized control trials (RCT), which demonstrated the safety of the procedure and the non-inferiority in terms of stroke reduction compared to OAC. Another device largely used is the Amplatzer Amulet (St. Jude Medical-Abbott). There is no RCT comparing this device with OAC, but many prospective and retrospective studies had shown the same safety profile and the non-inferiority with the OAC. From the very beginning of the LAAC, a crucial assessment is the degree of LAA occlusion granted by the implanted device. Many imaging modalities have been used to assess LAA occlusion, including transesophageal echocardiography (TEE), fluoroscopy or cardiac computed tomography angiography (CCTA). In the setting of available randomized trials, successful closure was defined with the presence of a regurgitant flow ≤ 5 mm assessed with TEE. In the last years several groups assessed the value of CCTA as non-invasive post-procedural surveillance imaging modality after endovascular LAAC to evaluate atrial-side device thrombus, residual leak (and mechanisms thereof), device position, pericardial effusion and most importantly LAA patency. There are currently no randomized controlled trials assessing the degree of LAA occlusion between Amulet and Watchman.

Conditions

Left Atrial Appendage Closure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Amplatzer Amulet

Left atrial appendage closure (LAAC) with Amplatzer Amulet implantation will be performed according to device specific instruction for use, based on both TEE guidance and angiography, femoral venous access and inter-atrial septum crossing.

Group Type: ACTIVE_COMPARATOR

Amplatzer Amulet for left atrial appendage closure

Intervention Type: DEVICE

The closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the Amplatzer Amulet will be performed according to device specific instruction for use, based on both TEE guidance and angiography, femoral venous access and inter-atrial septum crossing.

Watchman/FLX

Left atrial appendage closure (LAAC) with Watchman/FLX implantation will be performed according to device specific instruction for use, based on both TEE guidance and angiography, femoral venous access and inter-atrial septum crossing.

Group Type: ACTIVE_COMPARATOR

Watchman/FLX for left atrial appendage closure

Intervention Type: DEVICE

The closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the Watchman/FLX will be performed according to device specific instruction for use, based on both TEE guidance and angiography, femoral venous access and inter-atrial septum crossing.

Interventions

Amplatzer Amulet for left atrial appendage closure

The closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the Amplatzer Amulet will be performed according to device specific instruction for use, based on both TEE guidance and angiography, femoral venous access and inter-atrial septum crossing.

Intervention Type: DEVICE

Watchman/FLX for left atrial appendage closure

The closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the Watchman/FLX will be performed according to device specific instruction for use, based on both TEE guidance and angiography, femoral venous access and inter-atrial septum crossing.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Written informed consent
• Male or female subject aged 18 years or more with no upper age limit and willing to comply with the protocol
• Indication to a LAAC as indicated in study population (HAS BLEED ≥3 or High bleeding risk as defined by Munich consensus document and CHA2DS2-VASc≥2)

Exclusion Criteria

• New York Heart Association class IV congestive heart failure
• Atrial septal defect or atrial septal repair or closure device
• Single occurrence of atrial fibrillation
• Cardioversion or ablation procedure planned within 30 days
• Implanted mechanical valve prosthesis
• Heart transplantation
• Enrolled in another IDE or IND investigation of a cardiovascular device or an investigational drug
• Pregnant or pregnancy is planned during the course of the investigation
• Active infection of any kind
• Severe chronic kidney insufficiency (CrCl< 30 ml/min)
• Terminal illness with life expectancy < 1 yr
• Left ventricular ejection fraction < 20%
• Intra-cardiac thrombus or dense spontaneous echo contrast as visualized by TEE within 2 days before implant
• Significant mitral valve stenosis (ie, MV <1.5 cm2)
• Complex aortic atheroma with mobile plaque of the descending aorta and/or aortic arch
• Cardiac tumor

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

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Valgimigli, Prof

Role: STUDY_CHAIR

Fondazione Cardiocentro Ticino

Emmanuel Teiger, Prof

Role: PRINCIPAL_INVESTIGATOR

Hôpital Hôpitaux Universitaires Henri-Mondor

Nicolas Meneveau, Prof

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz

Frederic Anselme, Prof

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Hôpitaux De Rouen

Lorenz Räber, Prof

Role: STUDY_CHAIR

Inselspital, Bern University Hospital

Locations

Centre Hospitalier Universitaire de Charleroi

Charleroi, , Belgium

Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz

Besançon, , France

Hopital cardiologique Haut Lévêque CHU de Bordeaux

Bordeaux, , France

Hôpital Hôpitaux Universitaires Henri-Mondor

Créteil, , France

Centre Hospitalier Universitaire Hôpitaux De Rouen

Rouen, , France

IRCCS Policlinico S.Donato

Milan, , Italy

Bern University Hospital

Bern, Switzerland/Bern, Switzerland

Department of Cardiology, Cardiocentro Ticino

Lugano, , Switzerland

Countries

Belgium; France; Italy; Switzerland

References

Galea R, De Marco F, Aminian A, Meneveau N, Anselme F, Grani C, Huber AT, Teiger E, Iriart X, Angelillis M, Brugger N, Spirito A, Corpataux N, Franzone A, Vranckx P, Fischer U, Pedrazzini G, Bedogni F, Windecker S, Raber L, Valgimigli M. Design and Rationale of the Swiss-Apero Randomized Clinical Trial: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure. J Cardiovasc Transl Res. 2021 Oct;14(5):930-940. doi: 10.1007/s12265-020-10095-4. Epub 2021 Apr 21.

Reference Type: BACKGROUND

PMID: 33884564 (View on PubMed)

Galea R, De Marco F, Meneveau N, Aminian A, Anselme F, Grani C, Huber AT, Teiger E, Iriart X, Babongo Bosombo F, Heg D, Franzone A, Vranckx P, Fischer U, Pedrazzini G, Bedogni F, Raber L, Valgimigli M. Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: Primary Results of the SWISS-APERO Randomized Clinical Trial. Circulation. 2022 Mar 8;145(10):724-738. doi: 10.1161/CIRCULATIONAHA.121.057859. Epub 2021 Nov 6.

Reference Type: RESULT

PMID: 34747186 (View on PubMed)

Galea R, Perich Krsnik J, Peters AA, De Marco F, Aminian A, Meneveau N, Heg D, Grani C, Anselme F, Franzone A, Vranckx P, Fischer U, Bedogni F, Raber L, Valgimigli M. Incidence and Predictors of Persistent Left Atrial Appendage Patency and its Subtypes after Percutaneous Closure: a Pre-Specified Analysis of the SWISS-APERO Trial. Eur Heart J Cardiovasc Imaging. 2025 Aug 7:jeaf232. doi: 10.1093/ehjci/jeaf232. Online ahead of print.

Reference Type: DERIVED

PMID: 40795219 (View on PubMed)

Galea R, De Marco F, Aminian A, Meneveau N, Chalkou K, Anselme F, Grani C, Franzone A, Vranckx P, Fischer U, Valgimigli M, Raber L. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. 2025 Jul 8;86(1):3-14. doi: 10.1016/j.jacc.2025.03.535.

Reference Type: DERIVED

PMID: 40602941 (View on PubMed)

Galea R, Meneveau N, De Marco F, Aminian A, Heg D, Chalkou K, Grani C, Anselme F, Franzone A, Vranckx P, Fischer U, Bedogni F, Raber L, Valgimigli M. One-Year Outcomes After Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: A Prespecified Analysis of the SWISS-APERO Randomized Clinical Trial. Circulation. 2024 Feb 6;149(6):484-486. doi: 10.1161/CIRCULATIONAHA.123.067599. Epub 2023 Oct 24. No abstract available.

Reference Type: DERIVED

PMID: 37875064 (View on PubMed)

Galea R, Aminian A, Meneveau N, De Marco F, Heg D, Anselme F, Grani C, Huber AT, Teiger E, Iriart X, Franzone A, Vranckx P, Fischer U, Pedrazzini G, Bedogni F, Valgimigli M, Raber L. Impact of Preprocedural Computed Tomography on Left Atrial Appendage Closure Success: A Swiss-Apero Trial Subanalysis. JACC Cardiovasc Interv. 2023 Jun 12;16(11):1332-1343. doi: 10.1016/j.jcin.2023.02.027. Epub 2023 May 3.

Reference Type: DERIVED

PMID: 37316145 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SWISS-APERO

Identifier Type: -

Identifier Source: org_study_id