Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147336
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-02
First Post:
2023-11-19
Brief Title:
A Multi-center National Open-label Prospective Study to Evaluate the Performance of the V-Lap System
Sponsor:
Vectorious Medical Technologies Ltd
Organization:
Vectorious Medical Technologies Ltd
Study Overview
Official Title:
A Multi-center National Open Label Prospective Study to Evaluate the Safety Usability and Performance of the V-LAP System for Wirelessly Measuring and Monitoring Left Atrial Pressure Lap in Patients With Advanced CHF
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
None
Brief Summary:
The objective of this study is to evaluate the safety and performance of the V-LAP System in subjects with New York Heart Association NYHA functional class II and III HF irrespective of left ventricular ejection fraction
Detailed Description:
The V- LAP System is intended for wirelessly measuring and monitoring LAP The V-LAP System is indicated for subjects with chronic symptomatic ACCAHA Stage C subjects Heart Failure
Pressure-guided medical management of study participants with the goal of reducing hospitalizations and improving quality of life will be implemented using a physician-directed patient self-management approach
V-LAP-PSM Patient Self-management Patient Guidance Application is a smartphone application that guides the patient on how to self-adjust the treatment according to physician prescription and when to approach their healthcare provider HCP
Freedom from study Device andor system related Major Adverse Cardiac and Neurological Events MACNE as defined in the protocol up to six months post-procedure as adjudicated by the independent Clinical Events Committee
Pressure-guided medical management of study participants with the goal of reducing hospitalizations and improving quality of life will be implemented using a physician-directed patient self-management approach
V-LAP-PSM Patient Self-management Patient Guidance Application is a smartphone application that guides the patient on how to self-adjust the treatment according to physician prescription and when to approach their healthcare provider HCP
Freedom from study Device andor system related Major Adverse Cardiac and Neurological Events MACNE as defined in the protocol up to six months post-procedure as adjudicated by the independent Clinical Events Committee
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None