Left Atrial Appendage ClosureSWISS-APERONCT03399851
Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure. (SWISS-APERO)
A study testing Amplatzer Amulet for left atrial appendage closure and Watchman/FLX for left atrial appendage closure in people with Left Atrial Appendage Closure, run by Insel Gruppe AG, University Hospital Bern at 8 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Atrial Appendage Closure
- What is being tested?
- Amplatzer Amulet for left atrial appendage closure and Watchman/FLX for left atrial appendage closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 19 Jun 2018to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
France4 sites
Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz
Besançon, 25030
Hopital cardiologique Haut Lévêque CHU de Bordeaux
Bordeaux, 33600
Hôpital Hôpitaux Universitaires Henri-Mondor
Créteil, 94010
Centre Hospitalier Universitaire Hôpitaux De Rouen
Rouen, 76000
Switzerland2 sites
Bern University Hospital
Bern, Switzerland/Bern, 3010
Department of Cardiology, Cardiocentro Ticino
Lugano, 6900
About this study
Official title: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure: the SWISS-APERO Randomized Clinical Trial
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).
Read the 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
- Being tested
- Amplatzer Amulet for left atrial appendage closure, Watchman/FLX for left atrial appendage closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amplatzer Amulet for left atrial appendage closureDevice
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 closureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Watchman/FLX for left atrial appendage closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 45 days
Secondary outcomes (15)
All cause of death, stroke, systemic or pulmonary embolism and spontaneous myocardial infarction
Composite endpoint
Measured: 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
Measured: 45 days and 13 months
Cardiovascular death
Cardiovascular death
Measured: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Ischemic stroke
Ischemic stroke
Measured: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Haemorrhagic stroke
Haemorrhagic stroke
Measured: 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
Measured: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Procedure-related complications
Procedure-related complications
Measured: 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
Measured: 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
Measured: 45 days and 13 months
Number of device implantation attempts
Number of device implantation attempts
Measured: end of procedure
Total time procedure
Total time procedure (minutes)
Measured: end of procedure
x-ray dose
x-ray dose (cGy.cm2)
Measured: end of procedure
fluoroscopy duration
fluoroscopy duration (minutes)
Measured: end of procedure
amount of contrast used during the procedure
amount of contrast used during the procedure (ml)
Measured: end of procedure
LAA patency
LAA patency at 45 day by TEE in the per protocol and as treated populations
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start19 Jun 2018
- Primary completion9 Jul 2021
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Left Atrial Appendage ClosureStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Valgimigli, Prof, Study chair, Fondazione Cardiocentro TicinoEmmanuel Teiger, Prof, Principal investigator, Hôpital Hôpitaux Universitaires Henri-MondorNicolas Meneveau, Prof, Principal investigator, Centre Hospitalier Régional Universitaire Hôpital Jean MinjozFrederic Anselme, Prof, Principal investigator, Centre Hospitalier Universitaire Hôpitaux De RouenLorenz Räber, Prof, Study chair, Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399851
- Sponsor's protocol ID
- SWISS-APERO
- Acronym
- SWISS-APERO
- Status last verified
- May 2024
- First submitted
- 8 Jan 2018
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33884564Galea 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.
PubMed 34747186Galea 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.
PubMed 40795219Galea 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.
PubMed 40602941Galea 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.
PubMed 37875064Galea 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.
PubMed 37316145
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure: the SWISS-APERO Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03399851
- Acronym / sponsor ID
- SWISS-APERO / SWISS-APERO
- Conditions
- Left Atrial Appendage Closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amplatzer Amulet | Active comparator | Device: Amplatzer Amulet for left atrial appendage closureLeft 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. |
| Watchman/FLX | Active comparator | Device: Watchman/FLX for left atrial appendage closureLeft 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amplatzer Amulet for left atrial appendage closureThe 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. | Device | Amplatzer Amulet |
| Watchman/FLX for left atrial appendage closureThe 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. | Device | Watchman/FLX |
Primary outcome
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
Time frame: 45 days
Composite endpoint
15 secondary outcomes
All cause of death, stroke, systemic or pulmonary embolism and spontaneous myocardial infarction
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
Time frame: 45 days and 13 months
Cardiovascular death
Time frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Ischemic stroke
Time frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
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
Time frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
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
Time frame: 45 days and 6 months
Device thrombosis
Time frame: 45 days and 13 months
Number of device implantation attempts
Time frame: end of procedure
Total time procedure
Time frame: end of procedure
x-ray dose
Time frame: end of procedure
fluoroscopy duration
Time frame: end of procedure
amount of contrast used during the procedure
Time frame: end of procedure
LAA patency
Time frame: 45 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Background: PubMed 33884564Galea 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.
- Results publication: PubMed 34747186Galea 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.
- Derived from this study: PubMed 40795219Galea 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.
- Derived from this study: PubMed 40602941Galea 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.
- Derived from this study: PubMed 37875064Galea 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.
- Derived from this study: PubMed 37316145Galea 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Valgimigli, Prof study chair
Fondazione Cardiocentro Ticino
Emmanuel Teiger, Prof principal investigator
Hôpital Hôpitaux Universitaires Henri-Mondor
Nicolas Meneveau, Prof principal investigator
Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amplatzer Amulet for left atrial appendage closure and Watchman/FLX for left atrial appendage closure in people with Left Atrial Appendage Closure, run by Insel Gruppe AG, University Hospital Bern at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Switzerland, Belgium, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03399851, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.