Clinical Trials Detalhe
Confirm Rx Insertable Cardiac Monitor SMART Registry
General Information
Gender
ALL
Age
N/A
Phase
N/A
Study Type
OBSERVATIONAL
Location
Hospital Prof. Doutor Fernando Fonseca (Amadora, Portugal)
Hospital de Santa Cruz (Carnaxide, Portugal)
Centro Hospitalar do Alto Ave, Unidade de Guimarães (Creixomil, Portugal)
Hospital de Santo Andre - Centro Hospitalar de Leiria (Leiria, Portugal)
Santa Maria Hospital (Lisbon, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT03505801Summary
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.
Conditions
Cardiac Arrhythmias
Symptoms and Signs
Atrial Fibrillation
Eligibility
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.