Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-29 @ 12:43 PM
Study NCT ID:
NCT02571868
Status:
COMPLETED
Last Update Posted:
2015-10-08
First Post:
2015-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute and Cronic Evaluation of AV/PV and VV Delay IEGM Based Optimisation Algorithm-QuickSept Study
Sponsor:
Maria Vittoria Hospital
Organization:
Study Overview
Official Title:
Acute and Cronic Evaluation of AV/PV and VV Delay IEGM Based Optimisation Algorithm (QuickOpt™) Compared With Echocardiographic Method for Cardiac Resincronization Therapy in CRT Implants With Right Interventricular Basal-Mid Septum Placement of Leads (QuickSept Study)
Status:
COMPLETED
Status Verified Date:
2015-10
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:
QuickSept
Brief Summary:
AtrioVentricular (AV) and InterVentricular (VV) delay optimization can improve ventricular function in Cardiac Resynchronization Therapy (CRT) and is usually performed by means of echocardiography. St Jude Medical has developed an automated algorhythm which calculates the optimal AV and VV delays (QuickOptTM) based on Intracardiac ElectroGrams, (IEGM), within 2 minutes. So far, the efficacy of the algorhythm has been tested acutely with standard lead position at right ventricular (RV) apex. Aim of this project is to evaluate the algorhythm performance in the mid- and long-term with RV lead located in mid-septum.
Detailed Description:
Primary end-point was to evaluate the relationship between the series of aortic flow Velocity Time Integral (aVTI) values calculated by the two methods at the PV, AV, and VV interval settings recommended by both the QuickOptTM and the standard ECHO optimization in CRT-D patients, at three index times: pre-discharge, at 6-month and at 12-month follow-ups.
Secondary end-point was to define the correlation between the optimal AV, PV and VV intervals defined by ECHO, using aVTI measurements and by the QuickOptTM algorithm, IEGM-based.
Secondary end-point was to define the correlation between the optimal AV, PV and VV intervals defined by ECHO, using aVTI measurements and by the QuickOptTM algorithm, IEGM-based.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: