Tailor-CRT: Better application of Cardiac Resynchronization Therapy by automated and improved selection of location and timing of stimulation

Tailor-CRT: Better application of Cardiac Resynchronization Therapy by automated and improved selection of location and timing of stimulation - Tailor-CRT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40325

Enrollment

Registered

2014-07-15

Start date

2014-11-26

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Heart Failure

Interventions

Extra invasive acute hemodynamic measurements (LVdP/dtmax) measurements will be performed during CRT implantation. The invasive measurements will be used to optimize LV lead positioning and pacemake

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The study population consists of patients referred for CRT implantation, who have a class I indication for CRT according to current international guidelines. The patients will be recruited from the out-patient Pacemaker/ICD clinic and from the cardiology ward. ;Inclusion criteria: * Chronic heart failure with NYHA functional class II-IV * Left ventricular ejection fraction (LVEF) 120 ms * In sinus rhythm

Exclusion criteria

Exclusion criteria: * Atrial fibrillation * >=4 premature ventricular complexes on standard 12-lead ECG * Age 80 years * Incapable of giving informed consent * Moderate to severe aortic valve stenosis

Design outcomes

Primary

Measure	Time frame
Main study endpoints * Agreement between the increase in LVdP/dtmax obtained at the optimal AV- and VV-interval as predicted by D-VCG and the largest increase in LVdP/dtmax during hemodynamic evaluation of AV- and VV-intervals. * Agreement between the increase in LVdP/dtmax obtained at the optimal LV lead position as predicted by VCG and LVLED and the largest increase in LVdP/dtmax during hemodynamic evaluation of potential LV lead positions.	—

Measure

Time frame

Main study endpoints * Agreement between the increase in LVdP/dtmax obtained at the optimal AV- and VV-interval as predicted by D-VCG and the largest increase in LVdP/dtmax during hemodynamic evaluation of AV- and VV-intervals. * Agreement between the increase in LVdP/dtmax obtained at the optimal LV lead position as predicted by VCG and LVLED and the largest increase in LVdP/dtmax during hemodynamic evaluation of potential LV lead positions.

—

Secondary

Measure	Time frame
Secondary study endpoint: * Agreement between QRS vector area, -angle and -amplitude on VCG with that on D-VCG.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)