Mechanistic insight in left ventricular septal and left bundle branch pacing.

Mechanistic insight in left ventricular septal and left bundle branch pacing. - MASTER-LV

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49575

Enrollment

Registered

2021-01-15

Start date

2021-05-19

Completion date

Unknown

Last updated

2025-03-17

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

Conditions

bradycardia heart failure

Interventions

All patients eligible for study participation have a clinical indication for permanent cardiac pacing and will receive a standard (CRT-)pacemaker implantation whether they decide to participate in t

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Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Indication for permanent cardiac pacing: o pacing indication in structurally normal heart because of: • sinus node dysfunction (SND) • atrioventricular block (AVB) • atrial tachyarrhythmia refractory to antiarrhythmic medications that required atrioventricular node ablation o Pacing indication with reduced LV ejection fraction (LVEF) • pacing indication with reduced LVEF and expected high percentage of ventricular pacing • Heart failure with wide QRS and left bundle branch block (LBBB) and reduced LVEF

Exclusion criteria

Exclusion criteria: • >2 premature ventricular complexes on standard 12-lead ECG on all ECG*s within 3 months prior to implantation. • Age

Design outcomes

Primary

Measure	Time frame
Primary study parameters/endpoints: • To show superiority in electrophysiological effect (standard deviation of activation times (SDAT) measured by the ECG-Belt) of LV septum pacing over RV septum pacing in patients indicated for permanent cardiac pacing.	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints: • Comparing vectorcardiographic characteristics (QRS area) during pacing at different depths within the IVS; • Comparing electrocardiographic characteristics (QRS duration, QRS morphology) during pacing at different depths within the interventricular septum (IVS); • Comparing systolic and diastolic blood pressure (invasively measured) during pacing at different depths within the IVS; • Determine the ability to capture the left bundle in LVS pacing; • Assess global and regional LV strain patterns measured by echocardiography during LVS pacing; • Assess reverse remodelling after three months in patients undergoing deep LV septal pacing with a CRT indication.	—

Measure

Time frame

Secondary study parameters/endpoints: • Comparing vectorcardiographic characteristics (QRS area) during pacing at different depths within the IVS; • Comparing electrocardiographic characteristics (QRS duration, QRS morphology) during pacing at different depths within the interventricular septum (IVS); • Comparing systolic and diastolic blood pressure (invasively measured) during pacing at different depths within the IVS; • Determine the ability to capture the left bundle in LVS pacing; • Assess global and regional LV strain patterns measured by echocardiography during LVS pacing; • Assess reverse remodelling after three months in patients undergoing deep LV septal pacing with a CRT indication.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)