Prospective Multicentric Study Comparing the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization Therapy Recipients

Study Overview
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Brief Summary
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Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality. Adjusting atrio-ventricular (AV) delay, vector optimization and choice of different modes of stimulation can influence the acute hemodynamical consequences of CRT but also its medium-term and long-term clinical and echocardiographic effects. The aim of the present prospective study is to investigate whether the different stimulation modes lead to different acute hemodynamic response, by evaluating the highest systolic pressure using the Finapress ® method.

Detailed Description
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This study is a non-randomized, prospective, interventional, multicentric study. Patients implanted with an Abbott ® CRT pacemaker or defibrillator since less than 3 months are eligible for the study. Recruited patients will be submitted to a non-invasive evaluation of different pacing modes. This will be performed using the Finapress NOVA device, which records blood pressure with a digital cuff. The peak of blood pressure will correspond to the optimal device settings Three modes of stimulation of ABBOTT CRT devices will be compared: Classical bi-ventricular pacing mode at nominal value and with AV delay optimization SyncAV mode at nominal value or with left ventricular preexcitation optimization Multipoint Pacing (MPP) mode, alone or in combination with SyncAV mode This is an acute evaluation study without scheduled follow-up.

Official Title
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Comparison of the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization.

Conditions
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Heart Failure, Cardiac Resynchronization Therapy

Intervention / Treatment
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* Other: Device programming of ABBOTT CRT pacemaker or defibrillator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient older than 18 Implantation of a CRT (CRT-P or CRT-D) less than 3 months before inclusion MPP and SyncAV-enabled ABBOTT Quadripolar CRT pacing system Patient who had signed an informed consent and is willing to comply with study requirements De novo implantation Patient covered by national healthcare insurance Exclusion Criteria: Permanent/persistant atrial fibrillation/ supra-ventricular tachycardia Pacing indication for 2nd or 3rd degree AV block Upgrading from non-CRT system Pregnant or breastfeeding women Adult under legal protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRT device<br>Patients implanted with a CRT device who will undergo a non-invasive hemodynamic evaluation of different pacing modes | Other: Device programming of ABBOTT CRT pacemaker or defibrillator<br>* Comparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session Comparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic response | Highest Systolic Blood Pressure (SBP) obtained by optimization of the mode of stimulation | day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other hemodynamical response | Cardiac output | day 0 | 
| Other hemodynamical response | Systolic ejection volume | day 0 | 
| Other hemodynamical response | dP/dT | day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Resynchronization Therapy, Atrioventricular delay optimization, Multipoint pacing, Negative atrioventricular hysteresis, Non invasive hemodynamic optimization, Heart Failure