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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)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implantation of LAA closure device
Sponsored by
Occlutech International AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
March 27, 2014
Last Updated
April 3, 2018
Sponsor
Occlutech International AB
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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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