Amplatzer™Amulet™ Post-Market Study (Amulet™PMS) (Amulet™PMS)
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|ClinicalTrials.gov Identifier: NCT02447081|
Recruitment Status : Completed
First Posted : May 18, 2015
Results First Posted : December 30, 2019
Last Update Posted : December 30, 2019
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation Thromboembolism Stroke||Device: Subjects implanted with Amulet Device|
A total of 1088 subjects were enrolled in the study at 61 sites internationally, outside the United States.
The study assessed acute and late serious adverse events and reports the rate of stroke and bleeding events through 2 years. No formal hypothesis were tested for this observational post-market study.
Each patient was followed at study visits at baseline, implant, 1-3 months, 6 months, 12 months, and 24 months post implant."
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||1088 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Amplatzer™Amulet™ Observational Post-Market Study|
|Actual Study Start Date :||June 1, 2015|
|Actual Primary Completion Date :||October 23, 2018|
|Actual Study Completion Date :||October 23, 2018|
Subjects implanted with Amulet Device
All subjects who receive the Amulet device will be followed.
Device: Subjects implanted with Amulet Device
Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
- Number of Participants With Acute Serious Adverse Events [ Time Frame: 0 to 7 days post procedure ]Acute adverse events were defined as those serious events with an onset date ≤ 7 days post-procedure
- Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure [ Time Frame: 7 days through 2 years ]Late adverse events were defined as those serious events with an onset date > 7 days post-procedure
- Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death [ Time Frame: Implant through 2 years ]Occurrence of ischemic stroke, systemic embolism, and cardiovascular death through 2 years
- Number of Participants With Major Bleeding Events [ Time Frame: Implant through 2 years ]Clinical events were adjudicated by the CEC as major bleeding events if they met the definition of Type 3 or greater on the Bleeding Academic Research Consortium (BARC) scale.
- Number of Participants With Technical Success [ Time Frame: During implant procedure, approximately 30 to 60 minutes ]Technical success is defined as successful implantation of the Amulet device in the left arterial appendage (LAA).
- Number of Participants With Procedural Success [ Time Frame: During the implant procedure and hospital stay, approximately 1 or 2 days ]Procedural success is based on Amulet device being implanted day 0 through hospital discharge, on average one night stay (day 1). Amulet device implanted and subject discharged the following day without an adverse event
- Number of Participants With Oral Anti-coagulation Usage [ Time Frame: At discharge, approximately 1 or 2 days after the procedure ]
- Number of Participants With Oral Anti-coagulation Usage [ Time Frame: At 1 to 3 months ]
- Number of Participants With Oral Anti-coagulation Usage [ Time Frame: At 6 months ]
- Number of Participants With Oral Anti-coagulation Usage [ Time Frame: At 12 months ]
- Number of Participants With Oral Anti-coagulation Usage [ Time Frame: At 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02447081
|Principal Investigator:||David Hildick-Smith, MD||Brighton and Sussex University Hospitals|
|Principal Investigator:||Claudio Tondo, MD PhD||University of Milan|