FRAGILEFrench Attitude Registry in Case of ICD Lead Replacement
Data Collection
Collected from today forward - ProspectiveCohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.559 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location