Atrial FibrillationOLAACNCT02105584
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
A study testing Implantation of LAA closure device in people with Atrial Fibrillation, run by Occlutech International AB at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Implantation of LAA closure device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Apr 2014to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Germany6 sites
Charité - Universitätsmedizin Berlin
Berlin
Kardiologie Universitätsklinikum Bonn
Bonn
Medizinische Klinikum Coburg
Coburg, 96450
CardioVascular Center Frankfurt
Frankfurt
Klinik für Innere Medizin Kardiologie Herzzentrum Leipzig GmbH
Leipzig
University Medical Center of Johannes Gutenberg-University Mainz
Mainz
United Kingdom1 site
NHS Trust (ICHNT) Hammersmith Hospital London
London
About this study
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
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Implantation of LAA closure device
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of LAA closure deviceDevice
Also called Occlutech LAA occluder in different sizes
| Study group | Role | What they receive |
|---|---|---|
| LAA closure device | Experimental | Implantation of LAA closure device Receives: Device: Implantation of LAA closure device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Occlutech International AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johannes Brachmann, Prof, Principal investigator, Klinikum Coburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105584
- Sponsor's protocol ID
- OCC201202
- Other IDs
- CIV-13-09-011614
- Acronym
- OLAAC
- Status last verified
- Apr 2018
- First submitted
- 27 Mar 2014
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02105584
- Acronym / sponsor ID
- OLAAC / OCC201202
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Occlutech International ABIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAA closure device | Experimental | Device: Implantation of LAA closure deviceImplantation of LAA closure device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of LAA closure deviceAlso: Occlutech LAA occluder in different sizes | Device | LAA closure device |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Brachmann, Prof principal investigator
Klinikum Coburg
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of LAA closure device in people with Atrial Fibrillation, run by Occlutech International AB at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful implantation of the Occlutech LAA closure device with less than 7% occurrence of major complications. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018; AzTrials last refreshed its copy on 6 Nov 2026.