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

NCT03399851 | Active Not Recruiting DMC

• 1 other identifier: SWISS-APERO
• Study Type: interventional
• Target: 200
• Locations: 4 countries
• Sites: 8

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).

Conditions

Left Atrial Appendage Closure

Outcome Measures

Primary Outcomes (1)

• Composite of left atrial appendage (LAA) patency at 45 day evaluated with cardiac computed tomography angiography (CCTA) or the crossover from one device to the other device based on morphological/anatomical considerations during device implantation

  Composite endpoint

  45 days

Secondary Outcomes (15)

• All cause of death, stroke, systemic or pulmonary embolism and spontaneous myocardial infarction

  48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years

• LAA patency at 45-day and 13-month CCTA in the per protocol and as treated populations

  45 days and 13 months

• Cardiovascular death

  48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years

• Ischemic stroke

  48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years

• Haemorrhagic stroke

  48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years

Study Arms (2)

Amplatzer Amulet

ACTIVE COMPARATOR

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.

Device: Amplatzer Amulet for left atrial appendage closure

Watchman/FLX

ACTIVE COMPARATOR

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.

Device: Watchman/FLX for left atrial appendage closure

Interventions

Amplatzer Amulet for left atrial appendage closure 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.

Amplatzer Amulet

Watchman/FLX for left atrial appendage closure 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.

Watchman/FLX

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (8)

Centre Hospitalier Universitaire de Charleroi

Charleroi, 6000, Belgium

Location

Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz

Besançon, 25030, France

Location

Hopital cardiologique Haut Lévêque CHU de Bordeaux

Bordeaux, 33600, France

Location

Hôpital Hôpitaux Universitaires Henri-Mondor

Créteil, 94010, France

Location

Centre Hospitalier Universitaire Hôpitaux De Rouen

Rouen, 76000, France

Location

IRCCS Policlinico S.Donato

Milan, 20097, Italy

Location

Bern University Hospital

Bern, Switzerland/Bern, 3010, Switzerland

Location

Department of Cardiology, Cardiocentro Ticino

Lugano, 6900, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 33884564 BACKGROUND

• 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.

  PMID: 34747186 RESULT

• 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 Oct 30;26(11):1795-1803. doi: 10.1093/ehjci/jeaf232.

  PMID: 40795219 DERIVED

• 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.

  PMID: 40602941 DERIVED

• 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.

  PMID: 37875064 DERIVED

• 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.

  PMID: 37316145 DERIVED

MeSH Terms

Interventions

Left Atrial Appendage Closure

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Marco Valgimigli, Prof

  Fondazione Cardiocentro Ticino

  STUDY CHAIR

• Emmanuel Teiger, Prof

  Hôpital Hôpitaux Universitaires Henri-Mondor

  PRINCIPAL INVESTIGATOR

• Nicolas Meneveau, Prof

  Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz

  PRINCIPAL INVESTIGATOR

• Frederic Anselme, Prof

  Centre Hospitalier Universitaire Hôpitaux De Rouen

  PRINCIPAL INVESTIGATOR

• Lorenz Räber, Prof

  Inselspital, Bern University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 16, 2018
• Study Start: June 19, 2018
• Primary Completion: July 9, 2021
• Study Completion: May 1, 2026
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); BE (1); IT (1); CH (2)