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)

April 3, 2018 updated by: Occlutech International AB

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charite - Universitatsmedizin Berlin
      • Bonn, Germany
        • Kardiologie Universitätsklinikum Bonn
      • Coburg, Germany, 96450
        • Medizinische Klinikum Coburg
      • Frankfurt, Germany
        • Cardiovascular center Frankfurt
      • Leipzig, Germany
        • Klinik für Innere Medizin Kardiologie Herzzentrum Leipzig GmbH
      • Mainz, Germany
        • University Medical Center of Johannes Gutenberg-University Mainz
  • United Kingdom
      • London, United Kingdom
        • NHS Trust (ICHNT) Hammersmith Hospital London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LAA closure device
Implantation of LAA closure device
Device: Implantation of LAA closure device
Other Names:
  • Occlutech LAA occluder in different sizes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Occlutech International AB

Investigators

  • Principal Investigator: Johannes Brachmann, Prof, Klinikum Coburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCC201202
  • CIV-13-09-011614 (Other Identifier: EUDAMED)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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