Status:
COMPLETED
Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
Ministry of Health, France
C. R. Bard
Conditions:
Heart Failure
Arrhythmia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Heart Failure (HF) with systolic dysfunction is associated with a poor prognosis in the long term despite the use of many effective drug treatment in reducing morbidity and mortality. In this context,...
Detailed Description
In this context, all measures that will reduce the risk of infection, will improve the prognosis of these patients. Thus, recent studies have shown greater effectiveness of local preparation for alcoh...
Eligibility Criteria
Inclusion
- Patients requiring cardiac resynchronization therapy (stage III-IV NYHA, EF ≤ 35%, left bundle branch block large (≥ 120 ms), optimal medical therapy) OR patients requiring the implementation of a resynchronization device on basis of the study PAVE (FE ≤ 45% + Atrial Fibrillation + need a radiofrequency atrioventricular node) OR patients requiring implantable pacemaker or implantable defibrillator but NYHA stage II, EF ≤ 35%; branch block left large (≥ 150 ms) optimal medical treatment OR patient requiring an upgrading at least 2 years after their last implementation
- Patient has consented free, informed
- Patients whose prognosis is not compromised by a morbid pathology in one year
- absence of contraindication to povidone-iodine alcoholic
- absence of contraindication to 2% chlorhexidine in alcohol or yellow-orange S (E110)
Exclusion
- Change case of cardiac resynchronization
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
April 23 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
2272 Patients enrolled
Trial Details
Trial ID
NCT01841242
Start Date
April 23 2013
End Date
January 31 2021
Last Update
June 4 2025
Active Locations (24)
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1
CH d'Aix en Provence
Aix-en-Provence, France, 13100
2
CHU d'Amiens
Amiens, France, 80000
3
CHU d'Angers
Angers, France, 49000
4
CH d'Annecy
Annecy, France, 74000