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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Maria Vittoria Hospital
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Correlation between QuickOptTM and standard ECHO optimization
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Dr.Massimo Giammaria
MD
Maria Vittoria Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients with CRT-D
- •stable and safe placement of an active-fixation RV lead on mid-interventricular septum;
- •achievement of an efficacious LV intravenous pacing from a Coronary Sinus (CS) branch.
Exclusion Criteria
- •Patients without spontaneous rhythm
Outcomes
Primary Outcomes
Correlation between QuickOptTM and standard ECHO optimization
Time Frame: 12-month
The primary endpoint was assessed by means the linear correlation analysis by the Pearson product-moment correlation coefficient to assess the agreement between the ECHO-based and the IEGM-based aVTIs for each of the AV/PV, and VV delay determinations