NCT01270646

Brief Summary

Impact of intraventricular electrical activation in resynchronization therapy. We seek to evaluate the impact of Cardiac Resynchronization Therapy (CRT) on electrical activation of the Left Ventricle (LV). The first goal of the study is to evaluate if CRT is able to decrease the heterogeneity of LV activation in heart failure patients. A second goal is to evaluate the electrical determinant of clinical response to CRT using invasive and non-invasive mapping technology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_2 heart-failure

Timeline
Completed

Started Jan 2011

Typical duration for phase_2 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

3.3 years

First QC Date

January 4, 2011

Last Update Submit

March 5, 2015

Conditions

Heart FailureCardiomyopathy, DilatedCoronary Disease

Keywords

Cardiac insufficiencyInvasive procedureHeart FailureNoninvasive procedureCongestive Heart FailureMappingCardiac resynchronisation therapyOpen studyCardiac Pacings, ArtificialHemodynamics

Outcome Measures

Primary Outcomes (1)

  • Evolution of the Global Left Ventricle activation time (LVATG) with and without Cardiac Resynchronization Therapy (CRT).

    Day 1 : End of CRT device implantation

Secondary Outcomes (7)

  • Number, area and location of line of conduction block in the Left Ventricle

    Day 1 : End of CRT device implantation

  • Area of the latest activated region of the Left Ventricle

    Day 1 : End of CRT device implantation

  • Number, area and location of LV region activated after the end of surface QRS

    Day 1 : End of CRT device implantation

  • Septal activation time (LVTAS)

    Day 1 : End of CRT device implantation

  • Global intra-Left Ventricular dispersion time

    Day 1 : End of CRT device implantation

  • +2 more secondary outcomes

Study Arms (1)

Intraventricular Electrical Activation

EXPERIMENTAL
Device: Invasive mapping with CARTO3 system and Non-Invasive mapping with CardioInsight Atlas EC Mapping system

Interventions

Invasive mapping with CARTO3 system and Non-Invasive mapping with CardioInsight Atlas EC Mapping systemDEVICE

Day 1: CRT device is implanted under general anesthesia in a conventional fashion. The coronary sinus leads will be implanted guided by the acute hemodynamic response (+(dP/dt)max) using a RADI guide wire. After device implantation, a steerable mapping catheter will be inserted in the Left Ventricle (LV) cavity to build a tridimensional activation map of the LV. This map will be obtained with and without CRT. From these maps different parameters describing LV activation will be measured and compared between patients with and without CRT. Day 5±2: A non-invasive map of the LV will be recorded with the CardioInsight ® system with and without CRT. The same parameters will be measured and compared with those obtained with invasive mapping.

Intraventricular Electrical Activation

Eligibility Criteria

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

You may qualify if:

  • Adult (aged 18 or above)
  • Sinus rhythm
  • Patient must have signed informed consent
  • Cardiac insufficiency of whatever cause (ischemic or non-ischemic)
  • Patient eligible for implantation of a ventricular resynchronization device or patient with a ventricular resynchronization device having a procedure of ventricular tachycardia ablation
  • Left ventricular ejection fraction \<35%
  • NYHA Class II to IV with optimal medical treatment
  • Patient covered by national healthcare insurance

You may not qualify if:

  • Pregnant woman
  • Sequel of transmural myocardial infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital cardiologique du Haut-Lévêque, Pr. Haïssaguerre's department, 3rd Floor

Pessac, 33604, France

Location

Related Publications (1)

  • Huntjens PR, Ploux S, Strik M, Walmsley J, Ritter P, Haissaguerre M, Prinzen FW, Delhaas T, Lumens J, Bordachar P. Electrical Substrates Driving Response to Cardiac Resynchronization Therapy: A Combined Clinical-Computational Evaluation. Circ Arrhythm Electrophysiol. 2018 Apr;11(4):e005647. doi: 10.1161/CIRCEP.117.005647.

    PMID: 29654125DERIVED

MeSH Terms

Conditions

Heart FailureCardiomyopathy, DilatedCoronary Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCardiomegalyCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMyocardial IschemiaVascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2011

First Posted

January 5, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2014

Study Completion

November 1, 2014

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

FR(1)