Confirm Rx Insertable Cardiac Monitor SMART Registry

Abbott

Status: Active, not recruiting

Conditions: Atrial Fibrillation; Symptoms and Signs; Cardiac Arrhythmias

Treatments: Device: Confirm Rx ICM insertion procedure

Study type: Observational

Funder types: Industry

Identifiers

NCT03505801

SJM-CIP-10176

Details and patient eligibility

About

The purpose of the Confirm Rx SMART Registry is to collect real world data to assess the safety and performance of the Confirm Rx Insertable Cardiac Monitor (ICM) and system over a 12 month period. A sub-set of subjects enrolled in the Confirm Rx SMART Registry will meet the Post Market Clinical Follow-Up (PMCF) requirement for CE mark.

Enrollment: 1,826 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Rx ICM device.
• 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.