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NCT Number: NCT02447081

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

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."

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fiona Stanley Hospital, Murdoch, Western Australia, Australia

Loading trial locations.

About this study

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."

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Subjects implanted with Amulet Device

Device

Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Amplatzer™Amulet™ Observational Post-Market Study

Acronym: Amulet™PMS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 18, 2015
Registry last updated
Dec 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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