Clinical trial NCT02105584: 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
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
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Occlutech International AB
Sponsor class: INDUSTRY
First posted: 2014-04-07
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Successful implantation of the Occlutech LAA closure device with less than 7% occurrence of major complications.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bonn
country: Germany
facility: Kardiologie Universitätsklinikum Bonn
city: Coburg
country: Germany
facility: Medizinische Klinikum Coburg
city: Frankfurt
country: Germany
facility: CardioVascular Center Frankfurt
city: Leipzig
country: Germany
facility: Klinik für Innere Medizin Kardiologie Herzzentrum Leipzig GmbH
city: Mainz
country: Germany
facility: University Medical Center of Johannes Gutenberg-University Mainz
city: London
country: United Kingdom
facility: NHS Trust (ICHNT) Hammersmith Hospital London
Study officials:
affiliation: Klinikum Coburg
name: Johannes Brachmann, Prof
role: PRINCIPAL_INVESTIGATOR
References: