NCT03779802

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

April 23, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2020

Completed
Last Updated

May 22, 2020

Status Verified

April 1, 2020

Enrollment Period

12 months

First QC Date

December 17, 2018

Last Update Submit

May 20, 2020

Conditions

Heart FailureCardiac Resynchronization Therapy

Keywords

Cardiac Resynchronization TherapyAtrioventricular delay optimizationMultipoint pacingNegative atrioventricular hysteresisNon invasive hemodynamic optimizationHeart Failure

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic response

    Highest Systolic Blood Pressure (SBP) obtained by optimization of the mode of stimulation

    day 0

Secondary Outcomes (3)

  • Other hemodynamical response

    day 0

  • Other hemodynamical response

    day 0

  • Other hemodynamical response

    day 0

Study Arms (1)

CRT device

EXPERIMENTAL

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

Interventions

Device programming of ABBOTT CRT pacemaker or defibrillatorOTHER

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.

CRT device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient older than 18
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Gehm Site D'Eaubonne

Eaubonne, Val-d'Oise, 95600, France

Location

Cmc Ambroise Pare

Neuilly-sur-Seine, 92200, France

Location

CHU Poitiers

Poitiers, France

Location

Related Publications (1)

  • 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.

    PMID: 33128179DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Defibrillators

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ElectrodesElectrical Equipment and SuppliesEquipment and Supplies

Study Officials

  • Ghassan MD MOUBARAK

    CMC Ambroise Paré

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2018

First Posted

December 19, 2018

Study Start

April 23, 2019

Primary Completion

April 18, 2020

Study Completion

April 18, 2020

Last Updated

May 22, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)