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Cardiac Arrhythmias
+2

Confirm Rx Insertable Cardiac Monitor SMART Registry

Sponsored by Abbott Medical Devices

About this trial

Last updated 9 months ago

Study ID

SJM-CIP-10176

Status

Active, not recruiting

Type

Observational [Patient Registry]

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 7 years ago

What is this trial 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.

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status