NCT04101253

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 16, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2023

Completed
Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

2.1 years

First QC Date

September 19, 2019

Last Update Submit

April 7, 2023

Conditions

Sudden Cardiac DeathImplantable Defibrillator

Outcome Measures

Primary Outcomes (1)

  • screening success rates

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

    one day

Study Arms (1)

Interventional

EXPERIMENTAL

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.

Procedure: new screening procedure with small variations in electrode positioning

Interventions

new screening procedure with small variations in electrode positioningPROCEDURE

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.

Interventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

CHRU de BREST

Brest, France

Location

CHU de Caen

Caen, France

Location

CHRU de Lille

Lille, France

Location

Hopital Saint Philivert

Lille, France

Location

CHU de Limoges

Limoges, France

Location

Hopitl Cardiologique Louis Pradel

Lyon, France

Location

CHU de Nancy

Nancy, France

Location

CHU de Nantes

Nantes, France

Location

AP-HP Hôpital européen Georges-Pompidou

Paris, France

Location

APHP - Pitié Salpêtrière

Paris, France

Location

CH de Pau

Pau, France

Location

CHU de Rennes

Rennes, France

Location

CHRU de Strasbourg

Strasbourg, France

Location

CHU deToulouse

Toulouse, France

Location

Clinique Pasteur

Toulouse, France

Location

CHU de Tours

Tours, France

Location

Related Publications (1)

  • 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.

    PMID: 38810921DERIVED

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 24, 2019

Study Start

December 16, 2019

Primary Completion

January 5, 2022

Study Completion

February 14, 2023

Last Updated

April 10, 2023

Record last verified: 2023-04

Locations

FR(16)