Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Invasive Closure of the Left Atrial Appendage (LAA) in Patients With Atrial Fibrillation
Sponsored by Occlutech International AB
About this trial
Last updated 7 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 8 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Documented paroxysmal, persistent or chronic non-valvular AF
- Calculated CHA2DS2 -VASC score equal or greater than 2 and/or HAS-BLED score equal or greater than 2
- Patients eligible or non-eligible for lifelong, oral anticoagulation therapy
- Life expectancy of at least 1 year
- Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
Exclusion Criteria
- Suspected or known intracardiac thrombus
- NYHA Class IV CHF
- Patients who has unstable and intractable angina pectoris
- ASD and/or atrial septal repair or closure device
- Recent myocardial infarction within 3 months
- Severe valvular heart disease, or implanted mechanical valve prosthesis
- Large PFO with significant atrial septal aneurysm
- Planned ablation procedure within 30 days of Occlutech LAA occluder® implant
- Resting heart rate > 110 bpm
- Allergy to Nitinol, which is a result of nickel and/or titanium allergies
- Stroke/TIA within the last 30 days
- Thrombocytopenia, thrombocytosis, leukopenia, or anemia
- Symptomatic carotid artery disease
- LVEF < 30%
- Mitral valve stenosis