Status:
COMPLETED
ConfirmRxTM: Posture and Activity
Lead Sponsor:
Abbott Medical Devices
Conditions:
Syncope
Cryptogenic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 u...
Detailed Description
Syncope is a condition that has vexed cardiologists worldwide due to its elusive nature. Often a third of patients with syncope remain undiagnosed despite assessments by multidisciplinary teams and th...
Eligibility Criteria
Inclusion
- Eligible patients will meet all the following:
- 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
- Patients will be excluded if they meet any of the following:
- 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.
- 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.
Key Trial Info
Start Date :
October 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03803969
Start Date
October 30 2018
End Date
July 30 2020
Last Update
January 14 2025
Active Locations (8)
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1
The Wesley Hospital
Auchenflower, Queensland, Australia, 4066
2
Friendly Society Private Hospital
Bundaberg, Queensland, Australia, 4670
3
Greenslopes Private Hospital
Greenslopes, Queensland, Australia, 4120
4
St Andrews Hospital
Adelaide, South Australia, Australia, 5000