Optimization of Cardiac Resynchronization Therapy with a Quadripolar Left Ventricular Lead

Optimization of Cardiac Resynchronization Therapy with a Quadripolar Left Ventricular Lead - OPTICARE-QLV

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44474

Enrollment

Registered

2014-07-16

Start date

2014-11-18

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

Chronic heart failure decompensation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with an indication for Cardiac Resynchronization Therapy according to the current international evidence based guidelines for CRT (the 2013 European Society of Cardiology Guidelines for cardiac pacing and cardiac resynchronization therapy): - Chronic heart failure; - New York Heart Association functional class II, III, IV (ambulatory); - QRS duration *120ms; - Left bundle branch block - Optimal pharmacological therapy; - Left ventricular ejection fraction *35%.

Exclusion criteria

Exclusion criteria: - Contraindications for implantation of a CRT device; - Age

Design outcomes

Primary

Measure	Time frame
The electrical delay at the quadripolar electrodes (expressed as QLVs) and its correlation with the acute hemodynamic response (expressed as %strokework).	—

Secondary

Measure	Time frame
The difference in acute hemodynamic benefit (strokework (%SW) and %dP/dt) between pacing with the optimal configuration of a quadripolar LV lead and multi point pacing, as compared to conventional biventricular pacing. Electrophysiological measurements of the LV electrodes (phrenic nerve stimulation, pacing threshold, sensing amplitude, impedance, RVP-LVS, LVP-RVS, LV1P-LV2S and LV2P-LV1S intervals Myocardial strain (derived by MRI), combined with pressure (derived from PV-loops) into pressure-strain loops to quantify myocardial (wasted) work. Quantifying reverse remodeling by measuring echocardiographic biplane (four-chamber and two-chamber view) end systolic volume (ESV). Reverse remodelingi is expressed as the percentage change in ESV between baseline and 6 months. QRS-duration and beat-to-beat variability of repolarization (BVR) by electrocardiogram (ECG).	—

Measure

Time frame

The difference in acute hemodynamic benefit (strokework (%SW) and %dP/dt) between pacing with the optimal configuration of a quadripolar LV lead and multi point pacing, as compared to conventional biventricular pacing. Electrophysiological measurements of the LV electrodes (phrenic nerve stimulation, pacing threshold, sensing amplitude, impedance, RVP-LVS, LVP-RVS, LV1P-LV2S and LV2P-LV1S intervals Myocardial strain (derived by MRI), combined with pressure (derived from PV-loops) into pressure-strain loops to quantify myocardial (wasted) work. Quantifying reverse remodeling by measuring echocardiographic biplane (four-chamber and two-chamber view) end systolic volume (ESV). Reverse remodelingi is expressed as the percentage change in ESV between baseline and 6 months. QRS-duration and beat-to-beat variability of repolarization (BVR) by electrocardiogram (ECG).

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Countries

Netherlands

Outcome results