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

Sponsor

CMC Ambroise Paré (Other)

Overall Status

Recruiting

CT.gov ID

NCT04206371

Collaborator

(none)

330

Enrollment

Locations

Arm

Anticipated Duration (Months)

47.1

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Implantable Cardioverter-Defibrillators	Diagnostic Test: Defibrillator threshold testing	N/A

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

Anticipated Enrollment :

330 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 3, 2020

Anticipated Primary Completion Date :

Feb 3, 2022

Anticipated Study Completion Date :

Feb 3, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Rate of defibrillator electrical integrity dysfunction during generator replacement. [4 hours]
Abnormal shock impedance value.

Secondary Outcome Measures

Rate of lead malfunction [12 months]
abnormal impedance value

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Trousseau	Chambray-lès-Tours	Centre-Val De Loire	France	37170
2	Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu-CHU de Nancy-Hôpitaux de Brabois	Vandœuvre-lès-Nancy	Grand Est	France	54500
3	CMC Ambroise Paré	Neuilly-sur-Seine	Ile-de-France	France	92200
4	CHU de Caen	Caen	Normandie	France	14000
5	CHU de Toulouse-Hôpital Rangueil	Toulouse	Occitanie	France	31400
6	Hôpital Privé du Confluent	Nantes,	Pays De La Loire	France	44277
7	Centre Hospitalier Henri Duffaut	Avignon	Provence-Alpes-Côte d'Azur	France	84902

Sponsors and Collaborators

CMC Ambroise Paré

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CMC Ambroise Paré

ClinicalTrials.gov Identifier:

NCT04206371

Other Study ID Numbers:

2019/08

First Posted:

Dec 20, 2019

Last Update Posted:

May 5, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by CMC Ambroise Paré

Defibrillation threshold testing

Defibrillation lead

Defibrillator replacement

Study Results

No Results Posted as of May 5, 2021