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 (OLAAC)

O

Occlutech

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Device: Implantation of LAA closure device

Study type

Interventional

Funder types

Industry

Identifiers

NCT02105584
OCC201202
CIV-13-09-011614 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

78 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

78 participants in 1 patient group

LAA closure device
Experimental group
Description:
Implantation of LAA closure device
Treatment:
Device: Implantation of LAA closure device

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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