Actively Recruiting
French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR
Led by Paris Sudden Death Expertise Center · Updated on 2024-12-20
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Paris Sudden Death Expertise Center
Lead Sponsor
E
European Georges Pompidou Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the extravascular implantable cardioverter-defibrillator (EV-ICD) for patients at risk of sudden cardiac death due to cardiac arrhythmia. This observational study aims to collect real-world data on the long-term safety and effectiveness of this newer device design, which offers advantages over traditional implantable cardioverter-defibrillators by placing the lead in the substernal space. The study is conducted nationwide in France to provide comprehensive evidence beyond previous smaller, specialized center trials. The EV-ICD device studied involves implanting a pulse generator along the left midaxillary line with a lead positioned substernally. This device is designed to deliver pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to conventional ICDs but with potentially improved outcomes. The study includes all patients receiving an EV-ICD implant in France and observes them over an average follow-up period of five years. Participants will be monitored throughout the study period for appropriate device therapies, early and late complications related to the EV-ICD, and overall mortality. Additional outcomes include interventions during follow-up and heart transplantation rates. Data collection will occur from implantation through hospital discharge and continue for about five years to assess long-term safety and effectiveness in a real-world setting.
CONDITIONS
Brief Title
French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients undergoing EV-ICD implantation
You will not qualify if you...
- Refusal of consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo implantation of the Extra-Vascular Implantable Cardioverter Defibrillator device.
1 visit (in-person)
Duration - Up to 5 years
Participants are monitored for early and late complications and overall health after device implantation.
Regular follow-up visits over 5 years
Trial Site Locations
Total: 1 location
1
European Georges Pompidou Hospital
Paris, France, 75015
Actively Recruiting
Research Team
E
Eloi MARIJON, MD, PhD
F
Fawzi KERKOURI, MD, MPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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