Data collection registry to assess the performance of Confirm RxTM Insertable Cardiac Monitor (ICM) and system over a 12 month period
- Conditions
- Health Condition 1: I48- Atrial fibrillation and flutter
- Registration Number
- CTRI/2019/06/019717
- Lead Sponsor
- St Jude Medical Abbott
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Eligible subjects will meet all of the following:
1. Have an approved indication for continuous arrhythmia monitoring with an ICM.
2. 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 doesnâ??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.
3. 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.
4. Are 18 years of age or older, or of legal age to give informed consent specific to state and national law.
Subjects will be excluded if they meet any of the following:
1. Subject is implanted with or indicated for implant with a pacemaker, implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) device.
2. 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.
3. Have a life expectancy of less than 1 year due to any condition.
4. Have a previous ICM placement.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the freedom from device SADEs and serious procedure related SAEs through 1 month post insertion procedure.Timepoint: 1-, 6- and 12-Month
- Secondary Outcome Measures
Name Time Method The following secondary endpoints to meet the PMCF requirements will be reported: <br/ ><br>â?¢ Freedom from device SADEs and procedure related SAEs through 12 months post insertion procedure. <br/ ><br>â?¢ R wave amplitude at scheduled follow-up intervals through 12 months post insertion procedure.Timepoint: 1-, 6- and 12-Month