NCT06739239

Brief Summary

Implantable cardioverter-defibrillators (ICDs) are widely recognized for their efficacy in reducing the risk of sudden cardiac death in high-risk patients. Nonetheless, there remains significant scope for improving outcomes through advancements in device technology and design. The extravascular cardioverter-defibrillator (EV-ICD) represents such an innovation, offering key advantages over other ICD systems. It incorporates a lead positioned in the substernal space, enabling the delivery of pause-prevention security pacing, antitachycardia pacing, and defibrillation energy similar to that provided by conventional transvenous ICDs. Previous studies have demonstrated that EV-ICDs can be implanted safely and are capable of terminating majority of induced ventricular arrhythmias during implantation; however, follow-up data are limited to highly experienced selected centers and over a relatively small follow-up period (6-month follow-up). The FOREVER cohort study, initiated by the French Institute of Health and Medical Research, aims to evaluate the EV-ICD use in France. This nationwide evaluation will provide an exhaustive collection of all EV-ICD implantations in France, offering valuable real-world evidence on the long-term safety and efficacy of the device.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Feb 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Feb 2024Dec 2030

Study Start

First participant enrolled

February 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

6.9 years

First QC Date

December 1, 2024

Last Update Submit

December 17, 2024

Conditions

Defibrillators, ImplantableSudden Cardiac Death Due to Cardiac Arrhythmia

Keywords

Implantable cardioverter defibrillatorsudden cardiac deathExtravascular Implantable Cardioverter-Defibrillator

Outcome Measures

Primary Outcomes (4)

  • Incidence of Appropriate Therapies

    The incidence of ICD shocks or ICD ATPs.

    Through the study completion, an average of 5 years

  • EV-ICD-related Early Complications (Prior to Hospital Discharge)

    The incidence of each complication related to the procedure or the device: pocket hematoma, infection, poor wound healing, inappropriate shocks, lead issues, pneumothorax, pericardial injury, other complications with details.

    Through the study completion, an average of 5 years

  • EV-ICD related Late Complications (After Hospital Discharge)

    The incidence of each complication related to the device or genetaor change procedure: infection, pocket hematoma, poor wound healing, inappropriate shocks, lead issues, premature battery depletion, chronic pain, painful pacing, EV-ICD related death

    Through the study completion, an average of 5 years

  • Overall and Specific Mortalities

    Incidence of deaths. Causes of Deaths: cardiovascular cause with the main raison leading to death, non-cardiovascular cause with the main raison leading to death, EV-ICD related death with details, and unknown cause.

    Through the study completion, an average of 5 years

Secondary Outcomes (2)

  • Interventions During Follow-up

    Through the study completion, an average of 5 years

  • Heart Transplantation

    Through the study completion, an average of 5 years

Study Arms (1)

All patients implanted with EV-ICD in France

Device: Extra-Vascular Implantable Cardioverter Defibrillator

Interventions

Extra-Vascular Implantable Cardioverter DefibrillatorDEVICE

The pulse generator is implanted along the patient's left midaxillary line, and the lead is positioned substernally.

All patients implanted with EV-ICD in France

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients implanted with an EV-ICD in France.

You may qualify if:

  • All patients undergoing EV-ICD implantation

You may not qualify if:

  • Refusal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Georges Pompidou Hospital

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Eloi MARIJON, MD, PhD

CONTACT

662833848eloi.marijon@aphp.fr

Fawzi KERKOURI, MD, MPH

CONTACT

7 67 14 95 58‬eecmcfawzikerkouri@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Cardiology Division

Study Record Dates

First Submitted

December 1, 2024

First Posted

December 18, 2024

Study Start

February 1, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

December 20, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

De-identified participant data (IPD) related to the primary and secondary outcomes of the study will be made available. This includes baseline characteristics, procedural details, follow-up outcomes, and information on complications or adverse events. All shared data will exclude any information that could potentially identify participants.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
From 01/01/2030 to 01/01/2035
Access Criteria
Access to the data will be granted upon reasonable request from qualified researchers, with active involvement of the study team in the project.

Locations

FR(1)