Confirm RxTM Insertable Cardiac Monitor SMART Registry

Completed

Conditions: dizzyness
Syncope
10007521

Registration Number: NL-OMON48966

Lead Sponsor: St. Jude Medical

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

• Have an approved indication for continuous arrhythmia monitoring with an ICM.
• Have a cellular phone or the ability or willing to use a St. Jude Medical
mobile transmitter that is compatible with the MyMerlin* App and able to
communicate with the Confirm RxTM ICM device. If a subject doesn*t have a cell
phone or loses their cell phone, then the site can provide a St. Jude Medical
mobile transmitter to the subject. The study will not provide cell phones.
• Have the ability to provide informed consent for study participation and be
willing and able to comply with the prescribed follow-up tests and schedule of
evaluations.
• Are 18 years of age or older, or of legal age to give informed consent
specific to state and national law.

Exclusion Criteria

• Subject is implanted with or indicated for implant with a pacemaker,
implantable cardioverter defibrillator (ICD), or cardiac resynchronization
therapy (CRT) device.
• Enrolled or intend to participate in a clinical drug and/or device study,
which could confound the results of this trial as determined by the sponsor,
during the course of this clinical study.
• Have a life expectancy of less than 1 year due to any condition.
• Have a previous ICM placement.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary safety endpoint is the freedom from serious adverse device effects<br /><br>(SADEs) and procedure related serious adverse events (SAEs) through 1 month<br /><br>post insertion procedure is greater than the pre-specified performance goal.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Freedom from device SADEs and procedure related SAEs through 12 months post<br /><br>insertion procedure.<br /><br>• R wave amplitude at scheduled follow-up intervals through 12 months post<br /><br>insertion procedure.</p><br>