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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-23

Study Completion Date

2020-04-18

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.

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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.

Conditions

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Heart Failure Cardiac Resynchronization Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CRT device

Patients implanted with a CRT device who will undergo a non-invasive hemodynamic evaluation of different pacing modes

Group Type EXPERIMENTAL

Device programming of ABBOTT CRT pacemaker or defibrillator

Intervention Type OTHER

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.

Interventions

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Device programming of ABBOTT CRT pacemaker or defibrillator

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.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No