Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-27 @ 10:39 PM
Study NCT ID:
NCT03775161
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-30
First Post:
2018-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
V-LAP™ Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heaRt Failure
Sponsor:
Vectorious Medical Technologies Ltd.
Organization:
Study Overview
Official Title:
A First in Human Multi-center, Open Label, Prospective Study to Evaluate the Safety, Usability and Performance of the V-LAP™ System
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
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:
VECTOR-HF
Brief Summary:
The purpose of the trial is to evaluate the safety, usability and performance of the V-LAP™ System in adult subjects with New York Heart Association (NYHA) Class III Heart Failure.
Detailed Description:
The trial is designed to demonstrate that the V-LAP™ implant can be positioned in the interatrial septum, and that Sensor pressure measurements correlate to standardized methods of intra-cardiac pressure measurements post-sensor implant and at the 3 month follow up visit. Safety will be monitored by the occurrence of adverse events throughout the trial.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: