Skip to content

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

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03779802
Acronym
3 STIM
Enrollment
50
Registered
2018-12-19
Start date
2019-04-23
Completion date
2020-04-18
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Resynchronization Therapy, Heart Failure

Keywords

Cardiac Resynchronization Therapy, Atrioventricular delay optimization, Multipoint pacing, Negative atrioventricular hysteresis, Non invasive hemodynamic optimization, Heart Failure

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.

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.

Interventions

OTHERDevice 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.

Sponsors

CMC Ambroise Paré
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hemodynamic responseday 0Highest Systolic Blood Pressure (SBP) obtained by optimization of the mode of stimulation

Secondary

MeasureTime frameDescription
Other hemodynamical responseday 0Cardiac output

Countries

France

Contacts

PRINCIPAL_INVESTIGATORGhassan MD MOUBARAK

CMC Ambroise Paré

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026