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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

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
NameTimeMethod
Freedom from device SADEs and serious procedure related SAEs1 month post insertion procedure
Secondary Outcome Measures
NameTimeMethod
Freedom from device SADEs and serious procedure related SAEs12 months post insertion procedure
R wave amplitude12 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

Scroll for more (101 remaining)
Arrhythmia Research Group
🇺🇸Jonesboro, Arkansas, United States

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