RECORD-VP: Real-time Evaluation of Cardiac Outpatient Recording Device With VitalPatch RTM
Withdrawn
- Conditions
- Arrhythmias, Cardiac
- Registration Number
- NCT04556240
- Lead Sponsor
- VitalConnect Inc.
- Brief Summary
The primary purpose of this study is to evaluate performance and safety of the VitalConnect Platform when used for mobile cardiac telemetry (MCT) or as an independent diagnostic testing facility (IDTF) system during activities of daily living by subjects 18 years or older who have been recommended MCT by their care provider.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Age 18 years or older;
- If recommended mobile cardiac telemetry (MCT) by the care provider
- If instructed, be willing to record information such as daily activities and symptoms
- Able to speak, read, and write English.
Exclusion Criteria
- Have extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed wear sites;
- Have a known allergy to medical adhesives;
- Have any potentially life-threatening condition that (for example ventricular tachycardia or ventricular fibrillation), in the opinion of the Investigator, would interfere with their participation in the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Successfully detect heart rhythm of the study subjects using VitalConnect platform as a mobile cardiac telemetry unit Each patient will be monitored for up-to 30 days Monitor the heart rhythm of the study subjects initially for up to 24 hours and if the monitoring finds the issue that the doctor is looking for, the monitoring will be stopped. In most of the cases, the monitoring can continue for up to 30 days for each study subject
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Site 1
🇺🇸Chevy Chase, Maryland, United States