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

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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02571868

Acronym

QuickSept

Enrollment

Registered

2015-10-08

Start date

2011-01-31

Completion date

2012-01-31

Last updated

2015-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

DEVICEOptimization CRT-D

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Correlation between QuickOptTM and standard ECHO optimization	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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026