Status:
UNKNOWN
Prospective Clinical Registry of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (S-ICD Korea Registry)
Lead Sponsor:
Yonsei University
Conditions:
Heart Failure
Sudden Cardiac Death
Eligibility:
All Genders
19+ years
Brief Summary
S-ICD avoids the use intravascular leads and their associated risks, has been increasingly used for primary and secondary prevention of sudden death. The long-term safety and feasible of S-ICD system ...
Detailed Description
The investigators propose to prospectively recruit 300 patients who are qualified to receive the EMBLEM S-ICD system by following the proposed BSC Patient Screening Steps in 10 sites in Korea. All pat...
Eligibility Criteria
Inclusion
- \> 18 years of age
- Patients with conventional indications for ICD and;
- Ability to provide informed consent and to complete the study and required follow-up
Exclusion
- planned cardiac surgery within 3 months of enrollment;
- pregnancy;
- life expectancy \<3 months;
- indication for CRT-D or permanent ventricular pacing for new implant;
- incessant ventricular tachycardia and/or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing; and
- patients with unipolar pacemakers or implanted devices that revert to unipolar pacing
Key Trial Info
Start Date :
May 10 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04127643
Start Date
May 10 2019
End Date
April 1 2024
Last Update
October 15 2019
Active Locations (1)
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1
Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea, 03722