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

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

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

Study Overview

• Status: Completed
• Conditions: Implantable Cardioverter-Defibrillators
• Intervention / Treatment: Diagnostic test: Defibrillator threshold testing

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 Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Centre-Val de Loire
    • Chambray-lès-Tours, Centre-Val de Loire, France, 37170
      • Hôpital Trousseau
  • Grand Est
    • Vandœuvre-lès-Nancy, Grand Est, France, 54500
      • Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu-CHU de Nancy-Hôpitaux de Brabois
  • Normandy
    • Caen, Normandy, France, 14000
      • CHU de Caen
  • Occitanie
    • Toulouse, Occitanie, France, 31400
      • CHU de Toulouse-Hôpital Rangueil
  • Pays de la Loire Region
    • Nantes, Pays de la Loire Region, France, 44277
      • Hôpital Privé du Confluent
  • Provence-Alpes-Côte d'Azur Region
    • Avignon, Provence-Alpes-Côte d'Azur Region, France, 84902
      • Centre Hospitalier Henri Duffaut
  • Île-de-France Region
    • Neuilly-sur-Seine, Île-de-France Region, France, 92200
      • CMC Ambroise Paré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Defibrillation testing during ICD replacment	Diagnostic test: Defibrillator threshold testing; Under general or local anesthesia. Induction of Ventricular Fibrillation or R-wave synchronized shock

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Defibrillator Electrical Integrity Dysfunction During Generator Replacement.	Number of Participants With Abnormal Shock Impedance Value.	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Lead Malfunction	Number of Participants With Abnormal Shock Impedance Value.	12 months

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): January 19, 2022
• Study Completion (Actual): June 27, 2023

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Defibrillation threshold testing; Defibrillation lead; Defibrillator replacement
• Other Study ID Numbers: 2019/08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No