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

Abbott

Status: Completed

Conditions: Thromboembolism; Atrial Fibrillation; Stroke

Treatments: Device: Subjects implanted with Amulet Device

Study type: Observational

Funder types: Industry

Identifiers

NCT02447081

SJM-CIP-10053

Details and patient eligibility

About

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."

Full 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."

Enrollment: 1,088 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,088 participants in 1 patient group

Subjects implanted with Amulet Device

Description:

All subjects who receive the Amulet device will be followed.

Treatment:

Device: Subjects implanted with Amulet Device