Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000803-33 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| C. R. Bard | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 alcoholic chlorhexidine (applicator containing 2% chlorhexidine and 70% alcohol isopropanolol) (AC 2%) compared to the aqueous povidone iodine (API)in general surgery. It has been shown that the rate of local infection was significantly reduced in the AC group vs 2%. aqueous povidone iodine, respectively vs. 9.5%. 16.1% (p = 0.004). No randomized trials have previously prospectively compared the interest of local preparation with AC 2% compared with the usual preparation by API during implantation Resynchronization devices. Based on experimental and clinical studies, and we hope this new approach to assess local skin preparation in the prevention of general and local risk of infection after implantation of a cardiac resynchronization device. To ensure consistency, and because of its high efficiency assumed on the basis of experimental and clinical studies, the choice fell on the revenue 2% with applicator and patients should benefit from a primary location or "up-grading" to a CR device.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alcoholic povidone iodine | Active Comparator | Betadine Alcoolique 5% One cutaneous application before implant procedure |
|
| alcoholic chlorhexidine | Experimental | ChloraPrep 2% One cutaneous application before implant procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alcoholic povidone iodine | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular event | Major cardiovascular events such as heart failure, embolic right heart. | 24 months |
| Side Effects | Side effects attributable to local treatment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Antoine DA COSTA, MD PhD | CHU de Saint-Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH d'Aix en Provence | Aix-en-Provence | 13100 | France | |||
| CHU d'Amiens |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41562534 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
2 randomized groups
Not provided
Not provided
Not provided
Not provided
| alcoholic chlorhexidine |
| Drug |
|
|
| 24 months |
| Amiens |
| 80000 |
| France |
| CHU d'Angers | Angers | 49000 | France |
| CH d'Annecy | Annecy | 74000 | France |
| CH d'Avignon | Avignon | France |
| CHU de Bordeaux | Bordeaux | 33000 | France |
| CHU de Brest | Brest | 29000 | France |
| CHU de Caen | Caen | 14000 | France |
| CH de Chartres | Chartres | 28000 | France |
| CHU de Clermont-Ferrand | Clermont-Ferrand | 63000 | France |
| CHU de Dijon | Dijon | 21000 | France |
| CHU de Grenoble | Grenoble | 38000 | France |
| CH la Rochelle | La Rochelle | 17000 | France |
| CHU de Lille | Lille | 59000 | France |
| Ch St Joseph St Luc | Lyon | 69000 | France |
| AP-HM | Marseille | 13000 | France |
| CHU de Montpellier | Montpellier | 34000 | France |
| CHU de Nimes | Nîmes | 30000 | France |
| CH de Périgueux | Périgueux | 24000 | France |
| CHU de Reims | Reims | 51000 | France |
| CHU de Rouen | Rouen | 76000 | France |
| CHU de Saint-Etienne | Saint-Etienne | 42000 | France |
| CHU de Strasbourg | Strasbourg | 67000 | France |
| CHU de Toulouse | Toulouse | 31000 | France |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001145 | Arrhythmias, Cardiac |
| D007239 | Infections |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided