Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)
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|ClinicalTrials.gov Identifier: NCT02447081|
Recruitment Status : Completed
First Posted : May 18, 2015
Last Update Posted : February 1, 2019
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation Thromboembolism Stroke||Device: Subjects implanted with Amulet Device|
Approximately 1000 subjects will be enrolled in the study to reduce the impact of individual center bias, each site may enroll up to 50 subjects. The study will be conducted at up to 75 sites internationally, outside the United States.
The study will be assessing acute and late serious adverse events and report on percentage of stroke and bleeding events through two years.
No formal hypothesis will be tested for this observational post-market study. However, point estimates and exact 95% confidence intervals will be provided for the primary and secondary objectives.
Each patient will be followed for a period of two years after enrollment. There will be no additional visits, nor procedures, for subjects who participate in the study. Subjects are expected to be followed at implant, 1-3 months post implant, 12 months and 24 months.
|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 31, 2018|
|Actual Study Completion Date :||October 31, 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.
- Assessment of acute serious adverse events [ Time Frame: 0 to 7 days post procedure ]
- Assessment of late serious adverse events greater than 7 days post procedure [ Time Frame: Greater than 7 days through 2 years ]
- Report the composite percentage of stroke (ischemic), systemic embolism and cardiovascular death [ Time Frame: implant through 2 years ]
- Report the percentage of bleeding events [ Time Frame: Implant through 2 years ]
- Technical success [ Time Frame: Implant procedure ]Was Amulet device implanted
- Procedural success [ Time Frame: Implant through hospital discharge ]Procedural success is based on Amulet device being implanted day 0 through hospital discharge, on average one night stay (day 1). Was Amulet device implanted and subject discharged the following day without an adverse event
- Oral anti-coagulation usage [ Time Frame: through 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02447081
Show 51 Study Locations
|Principal Investigator:||David Hildick-Smith, MD||Brighton and Sussex University Hospitals|
|Principal Investigator:||Claudio Tondo, MD PhD||University of Milan|