Defibrillation Testing During Implantable Cardioverter Defibrillator (ICD) Replacement (T-DEF)

  • STATUS
    Recruiting
  • End date
    Feb 3, 2023
  • participants needed
    330
  • sponsor
    CMC Ambroise Paré
Updated on 27 February 2022

Summary

This study will evaluate safety and clinical outcomes of a systematic defibrillation threshold testing in patient with indication for defibrillator replacement.

Description

Implantable cardioverter defibrillators (ICD) are strongly recommended in patients with left ventricular systolic function 35% or selected patients with channelopathies and cardiomyopathies.

Defibrillation threshold testing (DFT) defines the minimal energy required to successfully terminate a ventricular arrhythmia by an ICD. It remains the gold standard to evaluate the electrical integrity of the device. However inherent complications of this procedure have been registered, such as refractory ventricular fibrillation, and the need for this practice during implant and/or replacement of ICD has recently been questioned.

If several studies have led to abandonment of the DFT during initial ICD implant, its interest during replacement is still controversial. Indeed, the leads essential for the device electrical integrity are older, more fragile, and the ICD replacement may damage it.

Device replacement is indicated when battery reaches the point of Elective Replacement Interval (ERI).

Patients over 18 years old with indication for replacement of defibrillator will be included. Patient's informations (comorbidities, medical history and events during hospitalization or follow-up) and device characteristics will be collected. Procedure will be realized under local or general anesthesia and prophylactic antibiotic will be administrated. Leads will be tested before and after the implantation of the new device. After connexion of the new implanted device to the leads a DFT will be performed. Protocol of DFT will be decided by the physician who will chose between induction of ventricular fibrillation or R-wave synchronized shock. Patients will be followed for 6 and 12 months from the date of defibrillator replacement.

Details
Condition Implantable Cardioverter-Defibrillators
Treatment Defibrillator threshold testing
Clinical Study IdentifierNCT04206371
SponsorCMC Ambroise Paré
Last Modified on27 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with an ICD (VR or DR) or CRT-D undergoing generator replacement
Consent for participation
Affiliation to the French social security system

Exclusion Criteria

Atrial Fibrillation without effective anti-coagulation treatments
Severe Aortic valve stenosis
Stroke occurred in the previous month
Hemodynamic instability contraindicating the high energy shock
Contraindication for anesthesia
Pregnant or breastfeeding women
Communication difficulties or neuropsychiatric disorder
Patients under protection of the adults (guardianship, curators or safeguard of justice)
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