Actively Recruiting
French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR Evaluation of Long-Term Safety and Performance
Led by Paris Sudden Death Expertise Center · Updated on 2024-12-20
1000
Participants Needed
1
Research Sites
360 weeks
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
Implantable cardioverter-defibrillators (ICDs) help reduce the risk of sudden cardiac death in patients at high risk. This study focuses on the extravascular cardioverter-defibrillator (EV-ICD), a newer device with a lead placed under the sternum. The EV-ICD delivers pacing and defibrillation similar to traditional ICDs but may offer advantages in safety and design. Previous research showed safe implantation and effective treatment of arrhythmias, but long-term data from broader use are limited. The study evaluates the use of the EV-ICD across France by collecting information on all implantations nationwide. The device involves implanting a pulse generator near the left midaxillary line and positioning the lead in the substernal space. This design aims to provide pause-prevention pacing, antitachycardia pacing, and defibrillation energy like conventional ICDs. Participants will be followed for about five years to monitor outcomes including appropriate therapies delivered by the device, early and late complications related to the EV-ICD, and overall mortality. The study gathers real-world evidence on the long-term safety and effectiveness of the EV-ICD, providing valuable insights from a wide range of patients receiving this treatment in clinical practice.
CONDITIONS
Official 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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here