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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
CMC Ambroise Paré

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : April 23, 2019
Actual Primary Completion Date : April 18, 2020
Actual Study Completion Date : April 18, 2020

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.




Primary Outcome Measures :
  1. Hemodynamic response [ Time Frame: day 0 ]
    Highest Systolic Blood Pressure (SBP) obtained by optimization of the mode of stimulation


Secondary Outcome Measures :
  1. Other hemodynamical response [ Time Frame: day 0 ]
    Cardiac output

  2. Other hemodynamical response [ Time Frame: day 0 ]
    Systolic ejection volume

  3. Other hemodynamical response [ Time Frame: day 0 ]
    dP/dT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
Gehm Site D'Eaubonne
Eaubonne, Val-d'Oise, France, 95600
Cmc Ambroise Pare
Neuilly sur seine, France, 92200
CHU Poitiers
Poitiers, France
Sponsors and Collaborators
CMC Ambroise Paré
Investigators
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Principal Investigator: Ghassan MD MOUBARAK CMC Ambroise Paré
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Responsible Party: CMC Ambroise Paré
ClinicalTrials.gov Identifier: NCT03779802    
Other Study ID Numbers: 2018/10
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CMC Ambroise Paré:
Cardiac Resynchronization Therapy
Atrioventricular delay optimization
Multipoint pacing
Negative atrioventricular hysteresis
Non invasive hemodynamic optimization
Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases