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)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implantation of LAA closure device
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility 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
Sites / Locations
- Charité - Universitätsmedizin Berlin
- Kardiologie Universitätsklinikum Bonn
- Medizinische Klinikum Coburg
- CardioVascular Center Frankfurt
- Klinik für Innere Medizin Kardiologie Herzzentrum Leipzig GmbH
- University Medical Center of Johannes Gutenberg-University Mainz
- NHS Trust (ICHNT) Hammersmith Hospital London
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LAA closure device
Arm Description
Implantation of LAA closure device
Outcomes
Primary Outcome Measures
Successful implantation of the Occlutech LAA closure device with less than 7% occurrence of major complications.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02105584
First Posted
March 27, 2014
Last Updated
April 3, 2018
Sponsor
Occlutech International AB
1. Study Identification
Unique Protocol Identification Number
NCT02105584
Brief Title
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
Acronym
OLAAC
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 Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Occlutech International AB
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LAA closure device
Arm Type
Experimental
Arm Description
Implantation of LAA closure device
Intervention Type
Device
Intervention Name(s)
Implantation of LAA closure device
Other Intervention Name(s)
Occlutech LAA occluder in different sizes
Primary Outcome Measure Information:
Title
Successful implantation of the Occlutech LAA closure device with less than 7% occurrence of major complications.
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Brachmann, Prof
Organizational Affiliation
Klinikum Coburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Kardiologie Universitätsklinikum Bonn
City
Bonn
Country
Germany
Facility Name
Medizinische Klinikum Coburg
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
CardioVascular Center Frankfurt
City
Frankfurt
Country
Germany
Facility Name
Klinik für Innere Medizin Kardiologie Herzzentrum Leipzig GmbH
City
Leipzig
Country
Germany
Facility Name
University Medical Center of Johannes Gutenberg-University Mainz
City
Mainz
Country
Germany
Facility Name
NHS Trust (ICHNT) Hammersmith Hospital London
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
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
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