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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02105584
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Occlutech International AB

Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Implantation of LAA closure device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LAA closure device
Implantation of LAA closure device
Device: Implantation of LAA closure device
Other Name: Occlutech LAA occluder in different sizes




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105584


Locations
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Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Kardiologie Universitätsklinikum Bonn
Bonn, Germany
Medizinische Klinikum Coburg
Coburg, Germany, 96450
CardioVascular Center Frankfurt
Frankfurt, Germany
Klinik für Innere Medizin Kardiologie Herzzentrum Leipzig GmbH
Leipzig, Germany
University Medical Center of Johannes Gutenberg-University Mainz
Mainz, Germany
United Kingdom
NHS Trust (ICHNT) Hammersmith Hospital London
London, United Kingdom
Sponsors and Collaborators
Occlutech International AB
Investigators
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Principal Investigator: Johannes Brachmann, Prof Klinikum Coburg

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Responsible Party: Occlutech International AB
ClinicalTrials.gov Identifier: NCT02105584    
Other Study ID Numbers: OCC201202
CIV-13-09-011614 ( Other Identifier: EUDAMED )
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes