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

Left Atrial Appendage Closure Clinical Trial

— SWISS-APERO  

Official title:

Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure: the SWISS-APERO Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03399851
• Other study ID #: SWISS-APERO
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 19, 2018
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: May 2026
• Est. primary completion date: July 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Echocardiographic exclusion criteria

• 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

Related Conditions & MeSH terms

• Left Atrial Appendage Closure

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Universitaire de Charleroi	Charleroi
France	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
Italy	IRCCS Policlinico S.Donato	Milano
Switzerland	Bern University Hospital	Bern	Switzerland/Bern
Switzerland	Department of Cardiology, Cardiocentro Ticino	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Countries where clinical trial is conducted

Belgium,  France,  Italy,  Switzerland, 

References & Publications (2)

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. — View Citation

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 Atria — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All cause of death, stroke, systemic or pulmonary embolism and spontaneous myocardial infarction	Composite endpoint	48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Secondary	LAA patency at 45-day and 13-month CCTA in the per protocol and as treated populations	LAA patency (arterial and/or venous phase) at 45-day and 13-month CCTA in the per protocol and as treated populations	45 days and 13 months
Secondary	Cardiovascular death	Cardiovascular death	48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Secondary	Ischemic stroke	Ischemic stroke	48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Secondary	Haemorrhagic stroke	Haemorrhagic stroke	48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Secondary	Bleeding events according to the BARC classification at each follow up	Bleeding events according to the BARC classification at each follow up	48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Secondary	Procedure-related complications	Procedure-related complications	48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Secondary	Rate of patients on (N)OAC at 45 days and 6 months	Rate of patients on (N)OAC at 45 days and 6 months	45 days and 6 months
Secondary	Device thrombosis	Device related thrombosis at 45 day TEE/CCTA and 13-month CCTA in the per protocol and as treated populations	45 days and 13 months
Secondary	Number of device implantation attempts	Number of device implantation attempts	end of procedure
Secondary	Total time procedure	Total time procedure (minutes)	end of procedure
Secondary	x-ray dose	x-ray dose (cGy.cm2)	end of procedure
Secondary	fluoroscopy duration	fluoroscopy duration (minutes)	end of procedure
Secondary	amount of contrast used during the procedure	amount of contrast used during the procedure (ml)	end of procedure
Secondary	LAA patency	LAA patency at 45 day by TEE in the per protocol and as treated populations	45 days