Status:
COMPLETED
Monitoring of Arrhythmias and HRV in Patients With Heart Failure Treated With the CRT Pacemaker Renewal TR2
Lead Sponsor:
Guidant Corporation
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this study is to evaluate the prevalence of sustained ventricular and supraventricular rhythm disorders in patients implanted with a CONTAK RENEWAL TR2 ventricular resynchronization t...
Eligibility Criteria
Inclusion
- Moderate or severe chronic heart failure, defined by the presence of NYHA class III or IV symptoms, Intra/interventricular synchronization disorder evaluated by echocardiography and/or Doppler Tissue Imaging (DTI, Yu's method22), Ejection fraction (EF) ≤ 40 %, If previous history of myocardial infarction, MI must be \> 60 days from the date of inclusion, Estimated life expectancy \> 6 months in the case of concomitant disease, Age ≥ 18 years, Optimal drug treatment of chronic heart failure (according to SFC\* recommendations).
Exclusion
- Conventional indication for treatment by implantable defibrillator upon inclusion, Cardiac transplant envisaged within 6 months, Unexplained syncope, MI \< 60 days before inclusion, Non compliance to drug treatment for chronic heart failure, Any coronary pathology which may be treated by revascularisation.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00180531
Start Date
February 1 2004
End Date
June 1 2007
Last Update
December 13 2007
Active Locations (10)
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1
CHG Albi
Albi, France, 81013
2
CHU Michalon
Grenoble, France, 38043
3
CH La Croix Rousse
Lyon, France, 69317
4
Hôpital Louis Pradel
Lyon, France, 69394