Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447896
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2024-05-28
Brief Title:
Clinical Validation of a Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System
Sponsor:
REEM Shenzhen Healthcare Co Ltd
Organization:
REEM Shenzhen Healthcare Co Ltd
Study Overview
Official Title:
A Open-label Randomised Paired Design Multicenter Study of a Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System With Intelligent Human-Machine Interaction for Assessing Cardiovascular Autonomic Neuropathy
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARTS
Brief Summary:
This is a open-label randomized paired design multicenter study of the Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System R6000 for evaluating cardiovascular autonomic neuropathy R6000 is novel intellectual diagnostic device for cardiovascular autonomic reflex tests and heart rate variability analysis A total of 85 subjects will be enrolled in trial Ⅰ and 150 subjects will be enrolled in trial Ⅱ In trial Ⅰ subjects will be randomized to two groups one of which will receive test by the tested device first and the other one will be tested by conventional blood pressure kit The primary objective of this clinical trial is to evaluate the effectiveness of the Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System The secondary objective is to evaluate the safety of the cardiovascular autonomic testing system and stability
Detailed Description:
Trial I Tested device Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System R6000 Control Conventional blood pressure kit Goal To assess the consistency between the tested device and the conventional method in measuring blood pressure
Trial IIa Tested device Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System R6000 Control Ambulatory holter station Goal To assess the consistency between the tested device and the conventional devices in measuring heart rate variability HRV
Trial IIb Tested device Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System R6000 Control Manual method with digital ECG machine stethoscope and sphygmomanometer Goal To assess the consistency between the tested device and the manual method in determining cardiovascular autonomic neuropathy CAN
Trial IIa Tested device Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System R6000 Control Ambulatory holter station Goal To assess the consistency between the tested device and the conventional devices in measuring heart rate variability HRV
Trial IIb Tested device Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System R6000 Control Manual method with digital ECG machine stethoscope and sphygmomanometer Goal To assess the consistency between the tested device and the manual method in determining cardiovascular autonomic neuropathy CAN
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None