ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study
Recruiting
- Conditions
- heart rhythm disturbancesventricular fibrillation10007521
- Registration Number
- NL-OMON54505
- Lead Sponsor
- Medtronic BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Patient has a Class I or IIa indication for implantation of an ICD according to
the Guidelines.
Patient is at least 18 years of age.
Exclusion Criteria
Patient is unwilling or unable to personally provide Informed Consent.
Patient has indications for bradycardia pacing x or Cardiac Resynchronization
Therapy (CRT).
Patients with an existing pacemaker, ICD, or CRT device or leads.
Patients with medical interventions or specific medical conditions as specified
in CIP.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of EV ICD in treating ventricular fibrillation compared to traditional ICDs?
How does the EV ICD demonstrate comparative effectiveness against standard-of-care implantable cardioverter defibrillators in managing heart rhythm disturbances?
Which biomarkers are associated with optimal patient selection for EV ICD therapy in ventricular fibrillation cases?
What adverse events have been reported with Medtronic BV's EV ICD and how do they compare to conventional ICD implantation risks?
Are there any combination therapies or competitor devices that enhance or challenge the efficacy of EV ICD in treating cardiac arrhythmias?