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 (OLAAC)

Occlutech

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Implantation of LAA closure device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02105584

OCC201202

CIV-13-09-011614 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

LAA closure device

Experimental group

Description:

Implantation of LAA closure device

Treatment:

Device: Implantation of LAA closure device