Syncope/Cardiac arrhythmia for investigation – BIOMASTER

Speciality

Cardiology

Description

To confirm the safety and efficacy of an implantable cardiac monitor (ICM) in patients who require long term cardiac monitoring due to suspected cardiac arrhythmia or unexplained syncope.

Eligibility criteria

To be considered for the study you must meet the following criteria:

  • At high risk of developing a clinically important cardiac arrhythmia, OR
  • Undergoing investigation for symptoms such as palpitations, pre-syncope or syncope that are suggestive of an underlying cardiac arrhythmia, OR
  • Undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke, OR
  • Planned for AF ablation procedure or have already undergone an AF ablation procedure
  • Must be willing and able to use remote home monitoring
Study details

Your participation in this study would be for approximately 12 months.

If you meet all eligibility criteria, you will be required to go into hospital for a day to have the device implanted.

Participants implanted with an ICM will have follow-up assessments prior to hospital discharge and at clinic visits at 10 days to 4 weeks, 3 months & 12 months post implant. Procedures conducted at the follow-up visits may include answering questions regarding the wearing comfort of the device, device interrogation and programming, check of the insertion location and device migration and device deficiency and adverse events assessments. In addition, after the first follow up visit, you will be required to wear an external Holter monitor for 48 hours to verify the accuracy and arrhythmia detection performance of the ICM.

You will be reimbursed for travel and study expenses.

Further information

NCT04025710