Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Inv… (NCT02105584) | Clinical Trial Compass
CompletedNot Applicable
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
Germany78 participantsStarted 2014-04
Plain-language summary
This is a prospective, non-randomized, study of the safety and efficacy of the Occlutech® LAA occluder indicated for percutaneous LAA closure in adult male or female patients with atrial fibrillation. Safety and efficacy will be assessed at day 1, 30 and 90, and after 1 year following implantation of an Occlutech® LAA Occluder.
Who can participate
Age range18 Years – 85 Years
SexALL
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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
What they're measuring
1
Successful implantation of the Occlutech LAA closure device with less than 7% occurrence of major complications.