Data collection registry to assess the performance of Confirm RxTM Insertable Cardiac Monitor (ICM) and system over a 12 month period

Completed

Brief Summary: This clinical investigation is intended tocollect real world data to assess the safety and performance of the Confirm RxTM InsertableCardiac Monitor (ICM) and system over a 12-month period. The Confirm RxTM SMART Registry willbe conducted in accordance with this CIP and applicable regulations.

Theprimary objective is to evaluate the freedom from serious adverse device effects(SADEs) and procedure related serious adverse events (SAEs) through 1-monthpost insertion procedure. Additionally, thestudy will assess the impact to quality of life in subjects inserted with the ConfirmRxTM ICM device andprovide feedback on the user experience with the Confirm RxTM ICM device and system.

The clinical studywill be conducted in approximately 100 centers worldwide. Up to 2000 subjects will be enrolled in this study. Enrollment in the study is expected to take approximately 18 months. The total duration of the clinicalinvestigation is expected to be approximately 30 months.

Recruitment & Eligibility

Inclusion Criteria

Eligible subjects will meet all of the following: 1.
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 MyMerlinâ„¢ 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.
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

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.
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.

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.	1-, 6- and 12-Month

Secondary Outcome Measures

Name	Time	Method
The following secondary endpoints to meet the PMCF requirements will be reported:	â€¢ Freedom from device SADEs and procedure related SAEs through 12 months post insertion procedure.

Locations (1): Advance Medicare Research Institute (AMRI) Hospital
🇮🇳
Kolkata, WEST BENGAL, India
Advance Medicare Research Institute (AMRI) Hospital
🇮🇳Kolkata, WEST BENGAL, India
Dr Prakash Hazra
Principal investigator
919830077307
prakashhazra@hotmail.com