Acute and Cronic Evaluation of AV/PV and VV Delay IEGM Based Optimisation Algorithm-QuickSept Study (QuickSept)

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)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Optimization CRT-D

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.

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• Italy
  • Torino, Italy
    • Ospedale Maria Vittoria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with CRT-D

Description

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:

• AF
• Patients without spontaneous rhythm

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between QuickOptTM and standard ECHO optimization	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	12-month

Collaborators and Investigators

• Sponsor: Maria Vittoria Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 5, 2015
• First Submitted That Met QC Criteria: October 7, 2015
• First Posted (Estimate): October 8, 2015

Study Record Updates

• Last Update Posted (Estimate): October 8, 2015
• Last Update Submitted That Met QC Criteria: October 7, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 002 (University of CT Health Center)