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OpenTrials
Completed

NCT Number: NCT03505801

Confirm Rx Insertable Cardiac Monitor SMART Registry

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.

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Key information

Conditions

Cardiac Arrhythmias Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Symptoms and Signs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Central de l'Armée, Algiers, Algeria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Confirm Rx ICM insertion procedure

Device

Insertion of Confirm Rx ICM device

Primary outcomes

  1. Freedom from device SADEs and serious procedure related SAEs

    Time frame: 1 month post insertion procedure

Secondary outcomes

  1. Freedom from device SADEs and serious procedure related SAEs

    Time frame: 12 months post insertion procedure

  2. R wave amplitude

    Time frame: 12 months post insertion procedure

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2026
First posted
Apr 23, 2018
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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