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

Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105584
• Other study ID #: OCC201202
• Secondary ID: CIV-13-09-011614
• Status: Completed
• Phase: N/A
• First received: March 27, 2014
• Last updated: April 3, 2018
• Start date: April 2014
• Est. completion date: September 2017

Study information

• Verified date: April 2018
• Source: Occlutech International AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Safety and efficacy will be assessed at day 1, 30 and 90, and after 1 year following implantation of an Occlutech® LAA Occluder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Implantation of LAA closure device

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Kardiologie Universitätsklinikum Bonn	Bonn
Germany	Medizinische Klinikum Coburg	Coburg
Germany	CardioVascular Center Frankfurt	Frankfurt
Germany	Klinik für Innere Medizin Kardiologie Herzzentrum Leipzig GmbH	Leipzig
Germany	University Medical Center of Johannes Gutenberg-University Mainz	Mainz
United Kingdom	NHS Trust (ICHNT) Hammersmith Hospital London	London

Sponsors (1)

Lead Sponsor	Collaborator
Occlutech International AB

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months