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French Attitude Registry in Case of ICD Lead Replacement (FRAGILE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01829269
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
French Cardiology Society

Brief Summary:

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.


Condition or disease
Defibrillator Explantation of Probe

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Study Type : Observational [Patient Registry]
Actual Enrollment : 559 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: French Attitude Registry in Case of ICD Lead Replacement
Actual Study Start Date : April 2013
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Group/Cohort
Patients with a defibrillator
The study population is that of patients with a defibrillator to have a change of probe.



Primary Outcome Measures :
  1. Explanted probes [ Time Frame: 2 years ]
    Percentage of explanted probes among implanted ones


Secondary Outcome Measures :
  1. Complications of explantation [ Time Frame: 2 years ]
    Percentage of events during and after explantation of probe



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Centers are hospitals recruiters French public or private, authorized to ask defibrillators and who agreed to participate in the study. A cardiologist referral will be designated for each hospital.

Patients with a defibrillator will be recruited during their hospitalization for change probe. Patients will receive full information about the purpose and conduct of the study.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829269


Locations
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France
Clinique Ambroise Paré
Neuilly Sur Seine, France, 92200
Sponsors and Collaborators
French Cardiology Society
Additional Information:
Publications:

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Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT01829269    
Other Study ID Numbers: 12 759
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019