Confirm Rx Insertable Cardiac Monitor SMART Registry

Active, not recruiting

• Conditions: Cardiac Arrhythmias; Atrial Fibrillation; Symptoms and Signs

• Registration Number: NCT03505801
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-04-13
• Study First Posted: 2018-04-23
• Study Start: 2018-04-24
• Primary Completion: 2019-09-19
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-25
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1826

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from device SADEs and serious procedure related SAEs	1 month post insertion procedure

Secondary Outcome Measures

Name	Time	Method
Freedom from device SADEs and serious procedure related SAEs	12 months post insertion procedure
R wave amplitude	12 months post insertion procedure

Trial Locations

Locations (111)

Arrhythmia Research Group; 🇺🇸 Jonesboro, Arkansas, United States

Bay Area Cardiology Associates PA; 🇺🇸 Brandon, Florida, United States

Bayfront Medical Center; 🇺🇸 Saint 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

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