Defibrillators, ImplantableFOREVERNCT06739239
French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR
An observational study of Defibrillators, Implantable and Sudden Cardiac Death Due to Cardiac Arrhythmia, run by Paris Sudden Death Expertise Center at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Defibrillators, Implantable, Sudden Cardiac Death Due to Cardiac Arrhythmia
- What is being tested?
- Extra-Vascular Implantable Cardioverter Defibrillator
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2024to 31 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients implanted with an EV-ICD in France.
Who may be able to join
- All patients undergoing EV-ICD implantation
Who cannot join
- Refusal of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
European Georges Pompidou Hospital
Paris, 75015
Eloi Marijon, Head of Cardiology Department, +33 6 62 83 38 48 ext. +33 1 56 09 30, eloi.marijon@aphp.fr
About this study
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.
- Being tested
- Extra-Vascular Implantable Cardioverter Defibrillator
- Keywords
- Implantable cardioverter defibrillator, sudden cardiac death, Extravascular Implantable Cardioverter-Defibrillator
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-Vascular Implantable Cardioverter DefibrillatorDevice
The pulse generator is implanted along the patient's left midaxillary line, and the lead is positioned substernally.
| Study group | Role | What they receive |
|---|---|---|
| All patients implanted with EV-ICD in France | Not described Receives: Device: Extra-Vascular Implantable Cardioverter Defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Appropriate Therapies
The incidence of ICD shocks or ICD ATPs.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Through the study completion, an average of 5 years
Secondary outcomes (2)
Interventions During Follow-up
Incidence and type of all EV-ICD related intervention. Raison of reintervention: complication, type of complication, generator change and pacing need.
Measured: Through the study completion, an average of 5 years
Heart Transplantation
The incidence of heart transplant during follow-up
Measured: Through the study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Defibrillators, ImplantableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Paris Sudden Death Expertise Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Georges Pompidou Hospital, University Hospital, Grenoble, University Hospital, Clermont-Ferrand, University Hospital, Rouen, Centre Hospitalier Universitaire de Besancon, Clinique du Millenaire, Institut Mutualiste Montsouris, Groupe Hospitalier Pitie-Salpetriere, University Hospital, Lille, University Hospital, Caen, Hospices Civils de Lyon, CHU de la Timone, Marseille, France, Centre Cardio-Thoracique de Monaco, Hospital of Lens, Institute Arnault Tzanck, France, University Hospital, Strasbourg, France, University Hospital, Limoges, University Hospital, Montpellier, Clinique Pasteur Toulouse, University Hospital, Bordeaux, University Hospital, Toulouse, Institut Jacques Cartier - Massy, Clinique Saint Augustin - Bordeaux, Rennes University Hospital, Clinique de la Sauvegarde, University Hospital of Saint-Etienne, Centre Hospitalier Universitaire, Amiens, Poitiers University Hospital, Clinique Saint-Gatien - Tours, CHU de Reims, Centre Hospitalier Universitaire Dijon, Hospital St. Joseph, Marseille, France, Centre Hospitalier Annecy Genevois, Clinique St Pierre, Perpignan, France, Bichat Hospital, Universite de La Reunion, University Hospital Center of Martinique, Henri Mondor University Hospital, University Hospital, Angers, Central Hospital, Nancy, France, Hôpital privé Clairval - Marseille, Médipôle Lyon-Villeurbanne, Hôpital Privé Les Franciscaines, Hospital Ambroise Paré Paris, Central Hospital, Metz Thionville, France, Hopital Prive Saint Martin - Bordeaux, Hôpital Privé de Parly II - Le Chesnay
- Responsible party
- Principal investigator, Marijon, European Georges Pompidou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739239
- Sponsor's protocol ID
- 2236443v0
- Acronym
- FOREVER
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR
- ClinicalTrials.gov ID
- NCT06739239
- Acronym / sponsor ID
- FOREVER / 2236443v0
- Keywords
- Implantable cardioverter defibrillator, sudden cardiac death, Extravascular Implantable Cardioverter-Defibrillator
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Paris Sudden Death Expertise CenterUniversity, hospital or other
- Collaborators
- European Georges Pompidou Hospital, University Hospital, Grenoble, University Hospital, Clermont-Ferrand, University Hospital, Rouen, Centre Hospitalier Universitaire de Besancon, Clinique du Millenaire, Institut Mutualiste Montsouris, Groupe Hospitalier Pitie-Salpetriere, University Hospital, Lille, University Hospital, Caen, Hospices Civils de Lyon, CHU de la Timone, Marseille, France, Centre Cardio-Thoracique de Monaco, Hospital of Lens, Institute Arnault Tzanck, France, University Hospital, Strasbourg, France, University Hospital, Limoges, University Hospital, Montpellier, Clinique Pasteur Toulouse, University Hospital, Bordeaux, University Hospital, Toulouse, Institut Jacques Cartier - Massy, Clinique Saint Augustin - Bordeaux, Rennes University Hospital, Clinique de la Sauvegarde, University Hospital of Saint-Etienne, Centre Hospitalier Universitaire, Amiens, Poitiers University Hospital, Clinique Saint-Gatien - Tours, CHU de Reims, Centre Hospitalier Universitaire Dijon, Hospital St. Joseph, Marseille, France, Centre Hospitalier Annecy Genevois, Clinique St Pierre, Perpignan, France, Bichat Hospital, Universite de La Reunion, University Hospital Center of Martinique, Henri Mondor University Hospital, University Hospital, Angers, Central Hospital, Nancy, France, Hôpital privé Clairval - Marseille, Médipôle Lyon-Villeurbanne, Hôpital Privé Les Franciscaines, Hospital Ambroise Paré Paris, Central Hospital, Metz Thionville, France, Hopital Prive Saint Martin - Bordeaux, Hôpital Privé de Parly II - Le Chesnay
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients implanted with EV-ICD in France | – | Device: Extra-Vascular Implantable Cardioverter Defibrillator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients implanted with an EV-ICD in France.
Key inclusion criteria (1 listed)
- All patients undergoing EV-ICD implantation
Key exclusion criteria (1 listed)
- Refusal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra-Vascular Implantable Cardioverter DefibrillatorThe pulse generator is implanted along the patient's left midaxillary line, and the lead is positioned substernally. | Device | All patients implanted with EV-ICD in France |
Primary outcome
Incidence of Appropriate Therapies
Time frame: Through the study completion, an average of 5 years
The incidence of ICD shocks or ICD ATPs.
EV-ICD-related Early Complications (Prior to Hospital Discharge)
Time frame: Through the study completion, an average of 5 years
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.
EV-ICD related Late Complications (After Hospital Discharge)
Time frame: Through the study completion, an average of 5 years
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
Overall and Specific Mortalities
Time frame: Through the study completion, an average of 5 years
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.
2 secondary outcomes
Interventions During Follow-up
Time frame: Through the study completion, an average of 5 years
Heart Transplantation
Time frame: Through the study completion, an average of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Defibrillators, Implantable and Sudden Cardiac Death Due to Cardiac Arrhythmia, run by Paris Sudden Death Expertise Center at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eloi MARIJON, MD, PhD (662833848 ext. +33, eloi.marijon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Appropriate Therapies (time frame: Through the study completion, an average of 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.