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OpenTrials
Completed

NCT Number: NCT01829269

French Attitude Registry in Case of ICD Lead Replacement

The average survival rate of a defibrillation lead is 91 to 99% at 2 years, 85-95% at 5 years and 60-72% at 8 years. We must also manage alerts for defibrillation probes with a higher complication rate than average. We will therefore be increasingly confronted with faulty sensors or at risk to be replaced.

There are no standardized approach for replacing defibrillation lead. A record made in the United States showed significant differences according to the teams strategy in case of failure of defibrillation lead in particular with regard to the decision to explant or abandon the probe.

The risk of extracting a defibrillation lead are well known with a major complication rate of 1.6 to 1.95%.

Regarding the risk of complications related to the abandonment of a probe we have less data. For some there is no risk to abandon a defibrillation lead. But others reported a complication rate of 5.5% related to pacing discontinued.

Main objective: Collect the attitude of different centers and different operators when replacing a failed defibrillation lead or "at risk." Explantation or abandonment of the sensor replaced.

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Key information

Conditions

Defibrillator Explantation of Probe

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Ambroise Paré

Neuilly-sur-Seine, 92200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient to receive a replacement defibrillation lead not motivated by an infection and having been informed.
  • Patient who agreed to participate in the study
  • Patients aged 18 years and over

No Exclusion Criteria

Treatment and study plan

Primary outcomes

  1. Explanted probes

    Time frame: 2 years

    Percentage of explanted probes among implanted ones

Secondary outcomes

  1. Complications of explantation

    Time frame: 2 years

    Percentage of events during and after explantation of probe

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Acronym: FRAGILE

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2013
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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