Status:
ACTIVE_NOT_RECRUITING
Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure. (SWISS-APERO)
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Left Atrial Appendage Closure
Eligibility:
All Genders
18+ years
Phase:
NA
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 frequ...
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03399851
Start Date
June 19 2018
End Date
May 1 2026
Last Update
May 23 2024
Active Locations (8)
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1
Centre Hospitalier Universitaire de Charleroi
Charleroi, Belgium, 6000
2
Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz
Besançon, France, 25030
3
Hopital cardiologique Haut Lévêque CHU de Bordeaux
Bordeaux, France, 33600
4
Hôpital Hôpitaux Universitaires Henri-Mondor
Créteil, France, 94010