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Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial

Phase: Pivotal
Status: Not Recruiting

This research study examines the most common sustained heart rhythm disorder, known as non-valvular atrial fibrillation (AF) and its effects of increased risk of stroke and systemic embolism or blood clots blocking an artery. Patients identified with AF experience arrhythmia, and these uncoordinated contractions decrease the amount of blood pumped through the atria. The insufficient contractions and slowing of the blood flow in the left atrium can increase the patients’ risk for blood clotting. The goal of this study is to compare the safety and efficacy of the Amulet device implant in the left atrial appendage (LAA) to the commercially available Boston Scientific LAA closure device (WATCHMAN®) and determine the overall reduction of blood clotting in this small pouch in the left atrium of the heart.

After the screening process, a patient is randomized to the treatment Amulet LAA occlusion device or to the control Boston Scientific LAA closure device. The Amulet device is placed in the heart using a catheter-based delivery system, inserted through a vein in the leg.

At 150 sites worldwide, 1400 people will be randomized in this research study. El Camino Hospital expects to enroll up to 30 subjects at this site.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • 18 years of age or older
  • Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF)
  • Suitable for LAA closure
  • At high risk of stroke or systemic embolism
  • Suitable for short term warfarin
  • Requires long-term oral anticoagulation therapy for a condition other than AF
  • Contraindicated for or allergic to aspirin, clopidogrel, or warfarin use
  • Has undergone atrial septal defect (ASD) repair or has an ASD closure device present
  • Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
  • Implanted with a mechanical valve prosthesis
  • Stroke or transient ischemic attack (TIA) within 90 days prior to randomization
  • Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to randomization, or intervention or surgery is planned within 60 days after implant procedure
  • Myocardial infarction (MI) within 90 days prior to randomization
  • New York Heart Association Class IV Congestive Heart Failure
  • Pregnancy

Principal Investigator

Chad Rammohan, MD

Sponsor

St. Jude Medical

NCT Number

NCT02879448

Contact

Janet Lamm, Clinical Research Coordinator
Taft Center for Clinical Research
650-962-4566
Janet_Lamm@elcaminohealth.org

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

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