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| Name | Class |
|---|---|
| Swiss National Fund for Scientific Research | OTHER |
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The aims are to compare Direct His Bundle Pacing (DHBP) with biventricular pacing (BiV) in terms of electrical resynchronization using electrocardiographic imaging (ECGI) and also in terms of acute hemodynamical effect using finger plethysmography and conduction velocimetry. The study will be a randomized crossover design with acute measurements.
By recruiting native conducting tissue to relay electrical activation of the ventricles via the Purkinje fibre network, DHBP may potentially achieve greater electrical resynchronization and hemodynamic benefit compared to BiV where the electrical activation wavefronts propagate from two discrete pacing sites. Electrical synchrony achieved by these pacing modes have however never been compared. Furthermore, the acute hemodynamic effect of DHBP has been compared to BiV only in a small single study to date. The aims are to compare DHBP with BiV in terms of electrical resynchronization using electrocardiographic imaging (ECGI) and also in terms of acute hemodynamical effect using finger plethysmography and conduction velocimetry. The primary endpoint will be left ventricular activation time, with secondary endpoints including various electrical (right ventricular activation time, total ventricular activation time etc) and hemodynamic parameters (systolic pressure, cardiac output, cardiac contractility). It is expected that DHBP offers shorter left ventricular activation time (i.e. better synchrony) and hemodynamic benefit compared to BiV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct His Bundle Pacing | Experimental | Pacing from the His bundle lead |
|
| Biventricular Pacing | Active Comparator | Pacing from the right ventricular and coronary sinus leads |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacing | Device | Programming of either Direct His Bundle pacing or biventricular pacing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular activation time | Duration of left ventricular electrical activation | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Right ventricular activation time | Duration of right ventricular electrical activation | 5 minutes |
| Total ventricular activation time | Duration of total ventricular electrical activation |
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Inclusion Criteria:
Treatment of heart failure with a standard indication for CRT (NYHA III-IV, LVEF < 35% and QRS > 130ms; or LVEF< 40% and requirement for frequent ventricular pacing, irrespective of baseline QRS duration) and optimal medical treatment.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Geneva | Geneva | Canton of Geneva | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33640346 | Derived | Zweerink A, Zubarev S, Bakelants E, Potyagaylo D, Stettler C, Chmelevsky M, Lozeron ED, Hachulla AL, Vallee JP, Burri H. His-Optimized Cardiac Resynchronization Therapy With Ventricular Fusion Pacing for Electrical Resynchronization in Heart Failure. JACC Clin Electrophysiol. 2021 Jul;7(7):881-892. doi: 10.1016/j.jacep.2020.11.029. Epub 2021 Feb 24. |
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| 5 minutes |
| Systolic pressure | Systolic blood pressure measured by finger plethysmography | 5 minutes |
| Cardiac output | Cardiac output measured by conductive velocimetry | 5 minutes |
| Cardiac contractility | Cardiac contractilit measured by conductive velocimetry | 5 minutes |