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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02105584

Acronym

OLAAC

Enrollment

Registered

2014-04-07

Start date

2014-04-30

Completion date

2017-09-30

Last updated

2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

DEVICEImplantation of LAA closure device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026