Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation

NCT01841242 | Completed Phase 4

• 2 other identifiers: 11080962012-000803-33
• Study Type: interventional
• Target: 2,272
• Locations: 1 country
• Sites: 24

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, cardiac resynchronization (CR), either alone or combined with a defibrillator function, has improved by about 30 to 40% of morbidity and mortality in this population of patients with heart failure. The information on the CR are now well established for patients with stage III-IV NYHA (New York Heart Association), with systolic dysfunction (EF ≤ 35%), presence of left bundle branch block wide (≥ 120 ms) and when medical treatment is optimal. As a result, the number of implanted devices continue to grow even if the implant procedures of cardiac resynchronization devices (CRD) are long, difficult and associated with significant complications with a risk of reoperation estimated between 10 and 15% . One of the most feared during implantation devices stimulation or defibrillation risk is represented by the risk of infection that will lead inevitably to explantation of the device. Despite the use of several preventive measures, including the use of an antiseptic shower, a local preparation for alcoholic povidone iodine (API) (PVPI 5% ethanol + 70%) and antibiotic prophylaxis clinical studies the most recent have clearly demonstrated that the risk of infection was associated with the duration of the intervention and was higher for procedures CR, it is noted in 2.4% in the short term and would be close to 3 to 4% in the medium term. Infections of implantable devices are associated with a poor prognosis, even in an excess mortality. It has been shown that the majority of infections may be linked to local contamination during surgery reinforcing the idea that prevention is mainly based on local measures and the reduction of operating time.

Conditions

Heart Failure; Arrhythmia

Keywords

Infection; Cardiac Resynchronization Device; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Infection

  Local or general infection in relation to the implantable device (skin erosion, externalization, local flow, local abscess, sepsis with or without bacteremia)

  24 months

Secondary Outcomes (2)

• Cardiovascular event

  24 months

• Side Effects

  24 months

Study Arms (2)

alcoholic povidone iodine

ACTIVE COMPARATOR

Betadine Alcoolique 5% One cutaneous application before implant procedure

Drug: alcoholic povidone iodine

alcoholic chlorhexidine

EXPERIMENTAL

ChloraPrep 2% One cutaneous application before implant procedure

Drug: alcoholic chlorhexidine

Interventions

alcoholic povidone iodine DRUG

Also known as: Betadine alcoolique 5%

alcoholic povidone iodine

alcoholic chlorhexidine DRUG

Also known as: ChloraPrep 2%

alcoholic chlorhexidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Change case of cardiac resynchronization
• Pregnant or breast-feeding women

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Ministry of Health, France: collaborator
• C. R. Bard: collaborator

Study Sites (24)

CH d'Aix en Provence

Aix-en-Provence, 13100, France

Location

CHU d'Amiens

Amiens, 80000, France

Location

CHU d'Angers

Angers, 49000, France

Location

CH d'Annecy

Annecy, 74000, France

Location

CH d'Avignon

Avignon, France

Location

CHU de Bordeaux

Bordeaux, 33000, France

Location

CHU de Brest

Brest, 29000, France

Location

CHU de Caen

Caen, 14000, France

Location

CH de Chartres

Chartres, 28000, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

CHU de Dijon

Dijon, 21000, France

Location

CHU de Grenoble

Grenoble, 38000, France

Location

CH la Rochelle

La Rochelle, 17000, France

Location

CHU de Lille

Lille, 59000, France

Location

Ch St Joseph St Luc

Lyon, 69000, France

Location

AP-HM

Marseille, 13000, France

Location

CHU de Montpellier

Montpellier, 34000, France

Location

CHU de Nimes

Nîmes, 30000, France

Location

CH de Périgueux

Périgueux, 24000, France

Location

CHU de Reims

Reims, 51000, France

Location

CHU de Rouen

Rouen, 76000, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

CHU de Strasbourg

Strasbourg, 67000, France

Location

CHU de Toulouse

Toulouse, 31000, France

Location

Related Publications (1)

• Da Costa A, Mansourati J, Eschalier R, Lesaffre F, Bordachar P, Taieb J, Laurent G, Milhem A, Kubala M, Le Page S, Milliez P, Gal B, Dompnier A, Defaye P, Bayle S, Anselme F, Cheggour S, Litalien J, Duparc A, Pasquier JL, Romeyer C, Botelho-Nevers E, Gagnaire J, Lager E, Garcin A, Chapelle C, Schimd A, Benali K, Laporte S, Deharo JC; CHLOVIS Study Investigators. Chlorhexidine vs Povidone-Iodine Alcohol Solutions for Cardiac Implantable Electronic Devices: A Prospective Randomized Study. J Am Coll Cardiol. 2026 Jan 20;87(2):200-211. doi: 10.1016/j.jacc.2025.10.042.

  PMID: 41562534 DERIVED

MeSH Terms

Conditions

Heart Failure; Arrhythmias, Cardiac; Infections

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoine DA COSTA, MD PhD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 randomized groups

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: April 26, 2013
• Study Start: April 23, 2013
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (24)