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

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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure; Cardiac Resynchronization Therapy
• Intervention / Treatment: Other: Device programming of ABBOTT CRT pacemaker or defibrillator

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Neuilly-sur-Seine, France, 92200
    • CMC Ambroise Paré
  • Poitiers, France
    • CHU Poitiers
  • Val-d'Oise
    • Eaubonne, Val-d'Oise, France, 95600
      • Gehm Site D'Eaubonne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré
• Investigators: Principal Investigator: Ghassan MD MOUBARAK, CMC Ambroise Paré

Publications and helpful links

General Publications

• Ferchaud V, Garcia R, Bidegain N, Degand B, Milliez P, Pezel T, Moubarak G. Non-invasive hemodynamic determination of patient-specific optimal pacing mode in cardiac resynchronization therapy. J Interv Card Electrophysiol. 2021 Nov;62(2):347-356. doi: 10.1007/s10840-020-00908-6. Epub 2020 Oct 30.
• Moubarak G, Sebag FA, Socie P, Villejoubert O, Louembe J, Ferchaud V. Interrelationships between interventricular electrical delays in cardiac resynchronization therapy. J Cardiovasc Electrophysiol. 2020 Sep;31(9):2405-2414. doi: 10.1111/jce.14629. Epub 2020 Jun 29.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2019
• Primary Completion (Actual): April 18, 2020
• Study Completion (Actual): April 18, 2020

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Heart Failure; Cardiac Resynchronization Therapy; Atrioventricular delay optimization; Non invasive hemodynamic optimization; Multipoint pacing; Negative atrioventricular hysteresis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Equipment and Supplies; Electrodes; Electrical Equipment and Supplies; Defibrillators
• Other Study ID Numbers: 2018/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No