SCREENING FOR THE IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE AUTOMATIC DEFIBRILLATOR

Not Applicable

Completed

• Conditions: Sudden Cardiac Death; Implantable Defibrillator
• Interventions: Procedure: new screening procedure with small variations in electrode positioning

• Registration Number: NCT04101253
• Lead Sponsor: Centre Hospitalier de PAU

Brief Summary

S-ICD (subcutaneous implantable cardioverter-defibrillator) screening failure occurs in about 10% of cases. Predictors of screening failure are not yet well determined. Moreover, slight variations in electrode positioning may change vector configuration and therefore improve screening success rates

Detailed Description

S-ICD (subcutaneous implantable cardioverter-defibrillator) has become the last years widespread in various pathological conditions and implantation rates are increasing each year worldwide. Previous to implantation it is mandatory to realize a screening in order to assess specific electrocardiographic vectors used to analyze cardiac rhythm. In routine practice, approximatively 10% of patients are recused for S-ICD device implantation due to failed screening 1-3. Causes are mainly abnormalities of R wave (low or high amplitude) and low R/T wave ratio. Determinants for screening failure have not yet been clearly studied. Moreover, it is a common finding in S-ICD implantation to find variations between pre-implant electrograms and electrograms recorded by the device. Variations of R wave amplitude and R/T ration are also observed with small variations of electrode positioning prior to implantation. It has been also shown that despite initial screening failure, S-ICD could be securely performed in some cases 4,5. Patients included in the study will undergo usual screening protocol. In case of failure a 2nd screening will be realize with slight electrode positioning variations compatible with S-ICD and lead placement. In case of success modality of implantation will be decided by physician.

In case of S-ICD implantation screening data will be compared to post implantation device electrograms. A 2 month follow-up will be performed with comparison of a new screening procedure with electrodes at the level of sub-cutaneous electrodes.

Study Timeline

• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-24
• Study Start: 2019-12-16
• Primary Completion: 2022-01-05
• Study Completion: 2023-02-14
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-07
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• The population will be composed of all patients referred for ICD method, aged over 18 years

Exclusion Criteria

• Age < 18 years old
• Patients who cannot freely give their consent, or patients who refuse to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional	new screening procedure with small variations in electrode positioning	Every ICD patient will undergo the standard screening process. Initial screening will be performed as usually performed by physician or Boston Scientific technical support. In case of one or more vector satisfying screening criteria, patient will be assigned in "screening success" group. In case of failure, a pre-determined electrode positioning protocol will be done with variation of para-sternal and axillary electrodes. Positioning variations will be left to the discretion of the operator cardiologist.

Primary Outcome Measures

Name	Time	Method
screening success rates	one day	Comparison of success rates between the standard screening procedure (without repositioning the electrodes) and the proposed new procedure (small variations in electrode positioning)

Trial Locations

Locations (16)

CHU de Limoges; 🇫🇷 Limoges, France

CHRU de BREST; 🇫🇷 Brest, France

CHRU de Lille; 🇫🇷 Lille, France

CHU de Caen; 🇫🇷 Caen, France

Hopital Saint Philivert; 🇫🇷 Lille, France

Hopitl Cardiologique Louis Pradel; 🇫🇷 Lyon, France

CHU de Nancy; 🇫🇷 Nancy, France

AP-HP Hôpital européen Georges-Pompidou; 🇫🇷 Paris, France

CHRU de Strasbourg; 🇫🇷 Strasbourg, France

CHU de Nantes; 🇫🇷 Nantes, France

CH de Pau; 🇫🇷 Pau, France

APHP - Pitié Salpêtrière; 🇫🇷 Paris, France

CHU de Rennes; 🇫🇷 Rennes, France

CHU de Tours; 🇫🇷 Tours, France

CHU deToulouse; 🇫🇷 Toulouse, France

Clinique Pasteur; 🇫🇷 Toulouse, France