ConfirmRxTM: Posture and Activity (NCT03803969) | Clinical Trial Compass
CompletedNot Applicable
ConfirmRxTM: Posture and Activity
Australia100 participantsStarted 2018-10-30
Plain-language summary
Insertable Cardiac Monitor's (ICM's) such as Confirm Rxâ„¢ are leadless devices implanted for long-term heart rhythm monitoring in the diagnosis and management of clinical conditions such as recurrent unexplained syncope, cryptogenic stroke, ventricular arrhythmias and monitoring atrial fibrillations (AF) post ablation. There is limited data on variations seen in signal sensing with changes in physical activity and posture. This single arm, non-randomized, open-label, multi-center, clinical investigation of 100 subjects is designed to characterise the safety and performance of Confirm RxTM by assessing quality of signal attained from the device with changes in posture and physical activity at implant and 30days post procedure. The study is also intended to assess gross migrations of the device at 30days post implant.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects are 18 years of age or older, or of legal age to give informed consent specific to state and national law.
✓. Subject must provide written informed consent prior to any clinical investigation related procedure.
✓. Have an approved indication for continuous arrhythmia monitoring with an Insertable Cardiac Monitor.
✓. Should be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
✓. Female subjects of child-bearing potential should have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
Exclusion criteria
✕. Subject has previously received an Insertable Cardiac Monitor.
✕. Subject is currently enrolled or intend to participate in another clinical investigation, which could confound the results of this trial during this clinical study as determined by the sponsor.
✕. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
What they're measuring
1
Characterisation of the safety and performance of Confirm Rxâ„¢ with changes in posture and physical activity at implant and 30days post procedure
✕. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.