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Clinical Trials/NCT04206371
NCT04206371CompletedNot Applicable

Longitudinal Follow-up of Patients With Defibrillator Threshold Testing During Implantable Cardioverter Defibrillator (ICD) Replacement

CMC Ambroise Paré14 sites in 1 country143 target enrollmentStarted: February 3, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
143
Locations
14
Primary Endpoint
Rate of defibrillator electrical integrity dysfunction during generator replacement.

Study Overview

Brief Summary

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

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Defibrillation testing during ICD replacment

Other

Intervention: Defibrillator threshold testing (Diagnostic Test)

Outcomes

Primary Outcomes

Rate of defibrillator electrical integrity dysfunction during generator replacement.

Time Frame: 4 hours

Abnormal shock impedance value.

Rate of Defibrillator Electrical Integrity Dysfunction During Generator Replacement.

Time Frame: 4 hours

Number of Participants With Abnormal Shock Impedance Value.

Secondary Outcomes

  • Rate of lead malfunction(12 months)
  • Rate of Lead Malfunction(12 months)

Investigators

Sponsor
CMC Ambroise Paré
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (14)

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