Confirm Rx Insertable Cardiac Monitor SMART Registry
Data Collection
Collected from today forward - ProspectiveArrhythmias, Cardiac+4
+ Atrial Fibrillation
+ Cardiovascular Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: April 24, 2018
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1826 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 113 locations
Kerckhoff-Klinik gGmbH
Bad Nauheim, GermanyUniversitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
Berlin, GermanyKlinikum Coburg GmbH
Coburg, Germany