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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
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
This will be a prospective, multicenter, observational, non-randomized study to compile real world outcome data on the use of the Amulet™device in non-valvular atrial fibrillation (NVAF) subjects. The study is designed to follow the Instructions For Use (IFU) to gather data on the implant procedure through two years of follow up with the Amulet™ device in a commercial clinical setting.

Condition or disease Intervention/treatment
Atrial Fibrillation Thromboembolism Stroke Device: Subjects implanted with Amulet Device

Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 1088 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Assessment of acute serious adverse events [ Time Frame: 0 to 7 days post procedure ]
  2. Assessment of late serious adverse events greater than 7 days post procedure [ Time Frame: Greater than 7 days through 2 years ]
  3. Report the composite percentage of stroke (ischemic), systemic embolism and cardiovascular death [ Time Frame: implant through 2 years ]
  4. Report the percentage of bleeding events [ Time Frame: Implant through 2 years ]

Secondary Outcome Measures :
  1. Technical success [ Time Frame: Implant procedure ]
    Was Amulet device implanted

  2. 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

  3. Oral anti-coagulation usage [ Time Frame: through 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with non-valvular atrial fibrillation
Criteria

Inclusion Criteria:

  1. Subject with history of paroxysmal, persistent or permanent NVAF
  2. Subject who is 18 years or older, or of legal age to give informed consent specific to state and national law
  3. Subject who is eligible for an Amulet LAA Occluder device according to current international guidelines and per physician discretion
  4. Subject who is willing and capable of providing informed consent, participating in all associated study activities

Exclusion Criteria:

  1. Subject with evidence of an intracardiac thrombus
  2. Subject with active infection or active endocarditis or other infections producing bacteremia
  3. Subject where the placement of the device would interfere with any intracardiac or intravascular structures
  4. Subject with any medical disorder that would interfere with completion or evaluation of clinical study results
  5. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)
  6. Subject with LAA anatomy that does not accommodate a device per the sizing guidelines

Information from the National Library of Medicine

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


  Show 51 Study Locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: David Hildick-Smith, MD Brighton and Sussex University Hospitals
Principal Investigator: Claudio Tondo, MD PhD University of Milan

Additional Information:

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02447081     History of Changes
Other Study ID Numbers: SJM-CIP-10053
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Atrial Fibrillation
Thromboembolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases