Atrial Fibrillation, Cardiac Arrhythmias, Symptoms and Signs
Conditions
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.
Interventions
DEVICEConfirm Rx ICM insertion procedure
Insertion of Confirm Rx ICM device
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from device SADEs and serious procedure related SAEs | 1 month post insertion procedure |
Secondary
| Measure | Time frame |
|---|---|
| Freedom from device SADEs and serious procedure related SAEs | 12 months post insertion procedure |
| R wave amplitude | 12 months post insertion procedure |
Countries
Algeria, Argentina, Austria, Belgium, Canada, Germany, Hungary, India, Israel, Italy, Japan, Kuwait, Latvia, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORFabio Quartieri, MD
Arcispedale S. Maria Nuova - IRCCS l
Outcome results
None listed