Prospective Multicentric Study Comparing the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization Therapy Recipients (3 STIM)
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|ClinicalTrials.gov Identifier: NCT03779802|
Recruitment Status : Terminated (With the current health situation, we do not anticipate a significant resumption of recruitment for several months.)
First Posted : December 19, 2018
Last Update Posted : May 22, 2020
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||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization.|
|Actual Study Start Date :||April 23, 2019|
|Actual Primary Completion Date :||April 18, 2020|
|Actual Study Completion Date :||April 18, 2020|
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.
- Hemodynamic response [ Time Frame: day 0 ]Highest Systolic Blood Pressure (SBP) obtained by optimization of the mode of stimulation
- Other hemodynamical response [ Time Frame: day 0 ]Cardiac output
- Other hemodynamical response [ Time Frame: day 0 ]Systolic ejection volume
- Other hemodynamical response [ Time Frame: day 0 ]dP/dT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779802
|Gehm Site D'Eaubonne|
|Eaubonne, Val-d'Oise, France, 95600|
|Cmc Ambroise Pare|
|Neuilly sur seine, France, 92200|
|Principal Investigator:||Ghassan MD MOUBARAK||CMC Ambroise Paré|