AMPLATZER™ Amulet™ LAA Occluder Trial "Amulet IDE"

Recruiting

Phase N/A Results N/A

Update History

20 Sep '17
The Summary of Purpose was updated.
New
The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the Amulet device or the WATCHMAN device and will be followed for 5 years after device implant.
Old
The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the Amulet device or the WATCHMAN device and will be followed for 5 years after device implant.
The eligibility criteria were updated.
New
Inclusion Criteria: 1. 18 years of age or older 2. Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and the patient has not been diagnosed with rheumatic mitral valvular heart disease 3. At high risk of stroke or systemic embolism defined as CHADS2 score > 2 or a CHA2DS2-VASc score of > 3 4. Has an appropriate rationale to seek an alternative to warfarin or other anticoagulation medication 5. Deemed by investigator to be suitable for short term warfarin therapy but deemed unable to take long term oral anticoagulation following the conclusion of shared decision making (see inclusion criteria #6) 6. Deemed suitable for LAA closure by a multidisciplinary team of medical professionals (including an independent non-interventional physician) involved in the formal and shared decision- making process, and by use of an evidence-based decision tool on oral anticoagulation (final determination must be documented in the subject's medical record) 7. Able to comply with the required medication regimen post-device implant 8. Able to understand and willing to provide written informed consent to participate in the trial 9. Able to and willing to return for required follow-up visits and examinations Exclusion Criteria: 1. Requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation 2. Contraindicated for or allergic to aspirin, clopidogrel, or warfarin use 3. Indicated for chronic P2Y12 platelet therapy inhibitor 4. Has undergone atrial septal defect (ASD) repair or has an ASD closure device implanted 5. Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted 6. Implanted with a mechanical valve prosthesis 7. Has any of the customary contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the transesophageal echocardiogram (TEE/TOE) probe or required catheters, or subject has active infection or bleeding disorder) 8. Stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure (as applicable) 9. 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 10. Myocardial infarction (MI) within 90 days prior to randomization 11. New York Heart Association Class IV Congestive Heart Failure 12. Left ventricular ejection Fraction (LVEF) <30% 13. Symptomatic carotid artery disease (defined as >50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is <50% stenosis 14. Reversible cause of AF (i.e. secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures) 15. History of idiopathic or recurrent venous thromboembolism 16. Left atrial appendage is obliterated or surgically ligated 17. Resting heart rate >110 bpm 18. Thrombocytopenia (defined as < 70,000 platelets/mm3) or anemia with hemoglobin concentration of < 10 g/dl (i.e. anemia as determined by the investigator which would require transfusion) 19. Hypersensitivity to any portion of the device material or individual components of either the Amulet or Boston Scientific LAA closure device (e.g. nickel allergy) 20. Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial 21. Subject is pregnant or pregnancy is planned during the course of the investigation 22. Active endocarditis or other infection producing bacteremia 23. Subject has a known malignancy or other illness where life expectancy is less than 2 years
Old
Inclusion Criteria: 1. 18 years of age or older 2. Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and the patient has not been diagnosed with rheumatic mitral valvular heart disease 3. At high risk of stroke or systemic embolism defined as CHADS2 score > 2 or a CHA2DS2-VASc score of > 3 4. Has an appropriate rationale to seek an alternative to warfarin or other anticoagulation medication 5. Deemed by investigator to be suitable for short term warfarin therapy but deemed unable to take long term oral anticoagulation following the conclusion of shared decision making (see inclusion criteria #6) 6. Deemed suitable for LAA closure by a multidisciplinary team of medical professionals (including an independent non-interventional physician) involved in the formal and shared decision- making process, and by use of an evidence-based decision tool on oral anticoagulation (final determination must be documented in the subject's medical record) 7. Able to comply with the required medication regimen post-device implant 8. Able to understand and willing to provide written informed consent to participate in the trial 9. Able to and willing to return for required follow-up visits and examinations Exclusion Criteria: 1. Requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation 2. Contraindicated for or allergic to aspirin, clopidogrel, or warfarin use 3. Indicated for chronic P2Y12 platelet therapy inhibitor 4. Has undergone atrial septal defect (ASD) repair or has an ASD closure device implanted 5. Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted 6. Implanted with a mechanical valve prosthesis 7. Has any of the customary contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the transesophageal echocardiogram (TEE/TOE) probe or required catheters, or subject has active infection or bleeding disorder) 8. Stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure (as applicable) 9. 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 10. Myocardial infarction (MI) within 90 days prior to randomization 11. New York Heart Association Class IV Congestive Heart Failure 12. Left ventricular ejection Fraction (LVEF) <30% 13. Symptomatic carotid artery disease (defined as >50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is <50% stenosis 14. Reversible cause of AF (i.e. secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures) 15. History of idiopathic or recurrent venous thromboembolism 16. Left atrial appendage is obliterated or surgically ligated 17. Resting heart rate >110 bpm 18. Thrombocytopenia (defined as < 70,000 platelets/mm3) or anemia with hemoglobin concentration of < 10 g/dl (i.e. anemia as determined by the investigator which would require transfusion) 19. Hypersensitivity to any portion of the device material or individual components of either the Amulet or Boston Scientific LAA closure device (e.g. nickel allergy) 20. Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial 21. Subject is pregnant or pregnancy is planned during the course of the investigation 22. Active endocarditis or other infection producing bacteremia 23. Subject has a known malignancy or other illness where life expectancy is less than 2 years
A location was updated in New York.
New
The overall status was updated to "Recruiting" at Columbia University Medical Center/New York Presbyterian Hospital.
5 May '17
Trial was updated to "N/A."
The gender criteria for eligibility was updated to "All."
31 Aug '16
Trial name was updated.
New
AMPLATZER™ Amulet™ LAA Occluder Trial