SCREENING FOR THE IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE AUTOMATIC DEFIBRILLATOR

NCT ID: NCT04101253

Last Updated: 2023-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-16
• Study Completion Date: 2023-02-14

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.

Conditions

Sudden Cardiac Death; Implantable Defibrillator

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Interventional

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.

Group Type: EXPERIMENTAL

new screening procedure with small variations in electrode positioning

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier de PAU

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHRU de BREST

Brest, , France

CHU de Caen

Caen, , France

CHRU de Lille

Lille, , France

Hopital Saint Philivert

Lille, , France

CHU de Limoges

Limoges, , France

Hopitl Cardiologique Louis Pradel

Lyon, , France

CHU de Nancy

Nancy, , France

CHU de Nantes

Nantes, , France

AP-HP Hôpital européen Georges-Pompidou

Paris, , France

APHP - Pitié Salpêtrière

Paris, , France

CH de Pau

Pau, , France

CHU de Rennes

Rennes, , France

CHRU de Strasbourg

Strasbourg, , France

CHU deToulouse

Toulouse, , France

Clinique Pasteur

Toulouse, , France

CHU de Tours

Tours, , France

Countries

France

References

de Guillebon M, Garcia R, Debeugny S, Bader H, Probst V, Bidegain N, Narayanan K, Mansourati J, Menet A, Ollitrault P, Marquie C, Guy-Moyat B, Mondoly P, Chevalier P, Badenco N, Behar N, Jesel-Morel L, Pierre B, Lellouche N, Deharo JC, Jacon P, Anselme F, Boveda S, Marijon E; SIS Study Investigators. Personalized screening before subcutaneous cardioverter-defibrillator implantation: Usefulness and outcomes in clinical practice-the S-ICD screening SIS prospective study. Heart Rhythm. 2024 Dec;21(12):2530-2535. doi: 10.1016/j.hrthm.2024.05.043. Epub 2024 May 27.

Reference Type: DERIVED

PMID: 38810921 (View on PubMed)

Other Identifiers

CHPAU2019/02

Identifier Type: -

Identifier Source: org_study_id