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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Implantation of LAA closure device

• Registration Number: NCT02105584
• Lead Sponsor: Occlutech International AB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-27
• Study Start: 2014-04
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-07
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LAA closure device	Implantation of LAA closure device	Implantation of LAA closure device

Primary Outcome Measures

Name	Time	Method
Successful implantation of the Occlutech LAA closure device with less than 7% occurrence of major complications.	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.

Trial Locations

Locations (7)

University Medical Center of Johannes Gutenberg-University Mainz; 🇩🇪 Mainz, Germany

CardioVascular Center Frankfurt; 🇩🇪 Frankfurt, Germany

Medizinische Klinikum Coburg; 🇩🇪 Coburg, Germany

Kardiologie Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Klinik für Innere Medizin Kardiologie Herzzentrum Leipzig GmbH; 🇩🇪 Leipzig, Germany

NHS Trust (ICHNT) Hammersmith Hospital London; 🇬🇧 London, United Kingdom