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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LAA closure device

Implantation of LAA closure device

Group Type EXPERIMENTAL

Implantation of LAA closure device

Intervention Type DEVICE

Interventions

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Implantation of LAA closure device

Intervention Type DEVICE

Other Intervention Names

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Occlutech LAA occluder in different sizes

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No