An interventional study of Amplatzer Amulet for left atrial appendage closure and Watchman/FLX for left atrial appendage closure in Left Atrial Appendage Closure, sponsored by Insel Gruppe AG, University Hospital Bern. Status unknown at 8 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Treatment
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).
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.
Insel Gruppe AG, University Hospital Bern is the lead sponsor of 737 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
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
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
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.
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.
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
Time frame: 45 days
All cause of death, stroke, systemic or pulmonary embolism and spontaneous myocardial infarction
Composite endpoint
Time frame: 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
LAA patency (arterial and/or venous phase) at 45-day and 13-month CCTA in the per protocol and as treated populations
Time frame: 45 days and 13 months
Cardiovascular death
Cardiovascular death
Time frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Ischemic stroke
Ischemic stroke
Time frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Haemorrhagic stroke
Haemorrhagic stroke
Time frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Bleeding events according to the BARC classification at each follow up
Bleeding events according to the BARC classification at each follow up
Time frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Procedure-related complications
Procedure-related complications
Time frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Rate of patients on (N)OAC at 45 days and 6 months
Rate of patients on (N)OAC at 45 days and 6 months
Time frame: 45 days and 6 months
Device thrombosis
Device related thrombosis at 45 day TEE/CCTA and 13-month CCTA in the per protocol and as treated populations
Time frame: 45 days and 13 months
Number of device implantation attempts
Number of device implantation attempts
Time frame: end of procedure
Total time procedure
Total time procedure (minutes)
Time frame: end of procedure
x-ray dose
x-ray dose (cGy.cm2)
Time frame: end of procedure
fluoroscopy duration
fluoroscopy duration (minutes)
Time frame: end of procedure
amount of contrast used during the procedure
amount of contrast used during the procedure (ml)
Time frame: end of procedure
LAA patency
LAA patency at 45 day by TEE in the per protocol and as treated populations
Time frame: 45 days
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Plan to share: No
Ran from Jun 2018 to primary completion in Jul 2021, 36 months.
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