Confirm Rx Insertable Cardiac Monitor SMART Registry

Completed

Conditions studied: Cardiac Arrhythmias, Symptoms and Signs, Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT03505801

Run by

Abbott Medical Devices

People needed

1826

Starts

2018-04-24

Expected to finish

2026-01-06

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bay Area Cardiology Associates PA — Brandon, Florida, United States
• Bayfront Medical Center — St. Petersburg, Florida, United States
• St. Luke's Regional Medical Center — Boise, Idaho, United States
• Kootenai Heart Clinics — Coeur d'Alene, Idaho, United States
• Iowa Heart Center — West Des Moines, Iowa, United States
• Kansas City Cardiac Arrhythmia Research Foundation — Overland Park, Kansas, United States
• MedStar Health Research Institute — Hyattsville, Maryland, United States
• Adventist HealthCare White Oak Medical Center — Silver Spring, Maryland, United States
• Cardiology Consultants of East Michigan — Flint, Michigan, United States
• Pinnacle Health System — Harrisburg, Pennsylvania, United States
• Cardiology Consultants of Philadelphia — Yardley, Pennsylvania, United States
• Erlanger Medical Center — Chattanooga, Tennessee, United States
• St. Thomas Hospital — Nashville, Tennessee, United States
• Ascension Texas Cardiovascular — Austin, Texas, United States
• Hôpital Central de l'Armée — Algiers, Algeria
• Instituto Argentino de Diagnostico y Tratamiento — Buenos Aires, Argentina
• Clinica Provincial — Merlo, Argentina
• Kepler Universitätsklinikum GmbH — Linz, Austria
• Krankenhaus der Stadt St. Pölten — Sankt Pölten, Austria
• Universitätsklinikum Tulln — Tulln, Austria
• Hopital Erasme — Brussels, Belgium
• Ziekenhuis Oost-Limburg — Genk, Belgium
• CHU Liège Sart Tilman — Liège, Belgium
• Foothills Medical Centre — Calgary, Alberta, Canada
• Arrhythmia Research Group — Jonesboro, Arkansas, United States

Full record on ClinicalTrials.gov

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