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

Sponsor

CMC Ambroise Paré (Other)

Overall Status

Terminated

CT.gov ID

NCT03779802

Collaborator

(none)

Enrollment

Locations

Arm

11.9

Actual Duration (Months)

16.7

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Cardiac Resynchronization Therapy	Other: Device programming of ABBOTT CRT pacemaker or defibrillator	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 23, 2019

Actual Primary Completion Date :

Apr 18, 2020

Actual Study Completion Date :

Apr 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CRT device 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 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.

Arm

Intervention/Treatment

Experimental: CRT device

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

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.

Outcome Measures

Primary Outcome Measures

Hemodynamic response [day 0]
Highest Systolic Blood Pressure (SBP) obtained by optimization of the mode of stimulation

Secondary Outcome Measures

Other hemodynamical response [day 0]
Cardiac output
Other hemodynamical response [day 0]
Systolic ejection volume
Other hemodynamical response [day 0]
dP/dT

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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