Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 6 for:    Amulet Observational study
Previous Study | Return to List | Next Study

Amplatzer™Amulet™ Post-Market Study (Amulet™PMS) (Amulet™PMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02447081
Recruitment Status : Completed
First Posted : May 18, 2015
Results First Posted : December 30, 2019
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. The study was 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:

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."

Layout table for study information
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 23, 2018
Actual Study Completion Date : October 23, 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. 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

  2. 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

  3. 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

  4. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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

  3. Number of Participants With Oral Anti-coagulation Usage [ Time Frame: At discharge, approximately 1 or 2 days after the procedure ]
  4. Number of Participants With Oral Anti-coagulation Usage [ Time Frame: At 1 to 3 months ]
  5. Number of Participants With Oral Anti-coagulation Usage [ Time Frame: At 6 months ]
  6. Number of Participants With Oral Anti-coagulation Usage [ Time Frame: At 12 months ]
  7. Number of Participants With Oral Anti-coagulation Usage [ Time Frame: At 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


Locations
Show Show 51 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
Layout table for investigator information
Principal Investigator: David Hildick-Smith, MD Brighton and Sussex University Hospitals
Principal Investigator: Claudio Tondo, MD PhD University of Milan
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02447081    
Other Study ID Numbers: SJM-CIP-10053
First Posted: May 18, 2015    Key Record Dates
Results First Posted: December 30, 2019
Last Update Posted: December 30, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Thromboembolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases