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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Universitätsmedizin Berlin, Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation of LAA closure device

Device

Other names: Occlutech LAA occluder in different sizes

Primary outcomes

Successful implantation of the Occlutech LAA closure device with less than 7% occurrence of major complications.

Time frame: 12 months

A major complication is defined as an event that results in death, procedure related stroke, systemic embolism, device embolisation, pericardial effusion (cardiac tamponade), or other major bleeding requiring invasive treatment or blood transfusions.

Sponsors and collaborators

Lead sponsor

Occlutech International AB

Industry

Registry information

Official study title

Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Invasive Closure of the Left Atrial Appendage in Patients With Atrial Fibrillation

Acronym: OLAAC

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Apr 7, 2014
Registry last updated: Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed