Confirm Rx Insertable Cardiac Monitor SMART Registry
- Conditions
- Cardiac ArrhythmiasAtrial FibrillationSymptoms 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
- 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.
- 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
Scroll for more (101 remaining)Arrhythmia Research Group🇺🇸Jonesboro, Arkansas, United States