NL-OMON54505
Recruiting
Not Applicable
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study - EV ICD study
Medtronic BV0 sites30 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- heart rhythm disturbances
- Sponsor
- Medtronic BV
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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