NCT00488410

Brief Summary

Patients showing a normal value of SDI (\< or + 8%) will randomly be assigned to CRT in "ON" or "OFF"mode at one month after implantation. In any case of emergency, an automated rescue mode is included in the device for the patients in "OFF" mode.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 2006

Typical duration for not_applicable

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

November 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 8, 2010

Status Verified

September 1, 2010

Enrollment Period

2.9 years

First QC Date

June 18, 2007

Last Update Submit

September 6, 2010

Conditions

Chronic Heart Failure

Keywords

Chronic heart failurereal time three-dimensional echocardiographycardiac resynchronization therapyventricular asynchronysystolic dysynchrony index

Outcome Measures

Primary Outcomes (1)

  • Three parallel arms, randomized, controlled, single blinded, monocentre, clinical trial.

Interventions

Doppler echocardiographyDEVICE

Eligibility Criteria

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

You may qualify if:

  • Both gender
  • Age\>18 years
  • Patients in functional class NYHA III or IV
  • Patient with ejection fraction \<or=150msec or with QRS between 120 and 149 msec but with echocardiographic evidences for cardiac dyssynchrony, such as those retained in the CARE-HF trial, e.g.two from the three following criterions :-Aortic pre-ejection delay\>140msec
  • Interventricular mechanical delay \>40msec
  • Delayed activation of the left ventricular postero-lateral wall
  • Written informed consentement

You may not qualify if:

  • Patient with atrial fibrillation
  • Absence of echogenicity
  • Patient with an indication for pacemaker implantation
  • Patient suffering from arterial pressure disorders, with systolic pressure greater than 170 or lower than 80 mmHg
  • Patient without social insurance policy
  • Drug or alcohol addiction
  • Any psychological disorder
  • Pregnant women
  • Patient with a transplanted organ

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clermont-Ferrand University Hospital

Clermont-Ferrand, Auvergne, 63000, France

Location

MeSH Terms

Interventions

Echocardiography, Doppler

Intervention Hierarchy (Ancestors)

EchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyUltrasonography, DopplerHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Bernard Citron, Pr

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 18, 2007

First Posted

June 20, 2007

Study Start

November 1, 2006

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

September 8, 2010

Record last verified: 2010-09

Locations

FR(1)