Syncope Clinical Trial
Official title:
ConfirmRxTM: Effects of Patient Posture and Physical Activity
Insertable Cardiac Monitor's (ICM's) such as Confirm Rx™ 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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | October 30, 2024 |
Est. primary completion date | October 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Eligible patients will meet all the following: 1. Subjects are 18 years of age or older, or of legal age to give informed consent specific to state and national law. 2. Subject must provide written informed consent prior to any clinical investigation related procedure. 3. Have an approved indication for continuous arrhythmia monitoring with an Insertable Cardiac Monitor. 4. Should be willing and able to comply with the prescribed follow-up tests and schedule of evaluations. 5. 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: Patients will be excluded if they meet any of the following: 1. Subject has previously received an Insertable Cardiac Monitor. 2. 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. 3. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. 4. 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. |
Country | Name | City | State |
---|---|---|---|
Australia | St Andrews Hospital | Adelaide | South Australia |
Australia | The Wesley Hospital | Auchenflower | Queensland |
Australia | Friendly Society Private Hospital | Bundaberg | Queensland |
Australia | Greenslopes Private Hospital | Greenslopes | Queensland |
Australia | Warringal Private Hospital | Heidelberg | Victoria |
Australia | The Valley Private Hospital | Mulgrave | Victoria |
Australia | St John of God Murdoch Hospital | Murdoch | Western Australia |
Australia | Mount Hospital | Perth | Western Australia |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Characterisation of the safety and performance of Confirm Rx™ with changes in posture and physical activity at implant and 30days post procedure | Patient performs defined movements post insertion of device and assessments are made on the Merlin Programmer. These are repeated 30+15 days post procedure | 30+15 days post procedure | |
Secondary | Identification of any gross migration of Confirm Rx device 30 days following implant | Measurements of location of the device is recorded post procedure and then measured again 30+15 days post procedure | 30+15 days post procedure |
Status | Clinical Trial | Phase | |
---|---|---|---|
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