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AzTrials

Heart FailurePhase 4CHLOVISNCT01841242

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

A Phase 4 study testing alcoholic povidone iodine and alcoholic chlorhexidine in people with Heart Failure and Arrhythmia, run by Centre Hospitalier Universitaire de Saint Etienne at 24 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Arrhythmia
What is being tested?
alcoholic povidone iodine and alcoholic chlorhexidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,272 participants
Where
24 sitesFrance
Study dates
23 Apr 2013to 31 Jan 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

France24 sites

  • CH d'Aix en Provence

    Aix-en-Provence, 13100

  • CHU d'Amiens

    Amiens, 80000

  • CHU d'Angers

    Angers, 49000

  • CH d'Annecy

    Annecy, 74000

  • CH d'Avignon

    Avignon

  • CHU de Bordeaux

    Bordeaux, 33000

  • CHU de Brest

    Brest, 29000

  • CHU de Caen

    Caen, 14000

  • CH de Chartres

    Chartres, 28000

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000

  • CHU de Dijon

    Dijon, 21000

  • CHU de Grenoble

    Grenoble, 38000

  • CH la Rochelle

    La Rochelle, 17000

  • CHU de Lille

    Lille, 59000

  • Ch St Joseph St Luc

    Lyon, 69000

  • AP-HM

    Marseille, 13000

  • CHU de Montpellier

    Montpellier, 34000

  • CHU de Nimes

    Nîmes, 30000

  • CH de Périgueux

    Périgueux, 24000

  • CHU de Reims

    Reims, 51000

  • CHU de Rouen

    Rouen, 76000

  • CHU de Saint-Etienne

    Saint-Etienne, 42000

  • CHU de Strasbourg

    Strasbourg, 67000

  • CHU de Toulouse

    Toulouse, 31000

Other trials in France

About this study

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.

Read the 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 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.

Being tested
alcoholic povidone iodine, alcoholic chlorhexidine
Keywords
Infection, Cardiac Resynchronization Device, Heart Failure
Medical subject headings
Heart Failure, Arrhythmias, Cardiac, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alcoholic povidone iodineDrug

    Also called Betadine alcoolique 5%

  • alcoholic chlorhexidineDrug

    Also called ChloraPrep 2%

Study groups in NCT01841242
Study groupRoleWhat they receive
alcoholic povidone iodineActive comparatorBetadine Alcoolique 5% One cutaneous application before implant procedure
Receives: Drug: alcoholic povidone iodine
alcoholic chlorhexidineExperimentalChloraPrep 2% One cutaneous application before implant procedure
Receives: Drug: alcoholic chlorhexidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infection

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

    Measured: 24 months

Secondary outcomes (2)

  1. Cardiovascular event

    Major cardiovascular events such as heart failure, embolic right heart.

    Measured: 24 months

  2. Side Effects

    Side effects attributable to local treatment.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2013 (estimated)
  2. Study start23 Apr 2013
  3. Primary completion31 Jan 2021
  4. Study completion31 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
2 randomized groups
Masking
None (open label)
Enrolment
2,272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01841242
Sponsor's protocol ID
1108096
Other IDs
2012-000803-33
Acronym
CHLOVIS
Status last verified
May 2025
First submitted
24 Apr 2013
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41562534

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing alcoholic povidone iodine and alcoholic chlorhexidine in people with Heart Failure and Arrhythmia, run by Centre Hospitalier Universitaire de Saint Etienne at 24 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infection (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01841242, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.

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