Clinical trial NCT04127643: Prospective Clinical Registry of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (S-ICD Korea Registry)
Official title: Prospective Clinical Registry of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (S-ICD Korea Registry)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Sudden Cardiac Death
Ventricular Tachycardia
Keywords: S-ICD
safety
feasibility
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who have received the EMBLEM S-ICD system

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 in Asian population with a smaller body size remain unclear. The investigators propose to perform a prospective study in Korean population to investigate the safety and feasibility of S-ICD for primary or secondary prevention of sudden cardiac death.

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 patients will be follow-up as standard of care to collect acute procedural and device related complications as well as long-term, device related, clinical and patient reported outcomes. Follow up data will be systematically collected over 24 months post-implant.

Eligibility criteria: Inclusion Criteria:

1. \> 18 years of age
2. Patients with conventional indications for ICD and;
3. Ability to provide informed consent and to complete the study and required follow-up

Exclusion Criteria:

1. planned cardiac surgery within 3 months of enrollment;
2. pregnancy;
3. life expectancy \<3 months;
4. indication for CRT-D or permanent ventricular pacing for new implant;
5. incessant ventricular tachycardia and/or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing; and
6. patients with unipolar pacemakers or implanted devices that revert to unipolar pacing

Primary outcomes:
measure: Perioperative S-ICD Complication Free Rate up to 7 days post implant
timeFrame: 7 days
measure: Perioperative S-ICD Complication Free Rate up to 30 days post implant
timeFrame: 30 days
measure: 1 year S-ICD Complication Free Rate
timeFrame: 1 year
measure: 2 year S-ICD Complication Free Rate
timeFrame: 2 year
measure: Percentage of inappropriate shocks for AF/SVT
timeFrame: 7 days
measure: Percentage of inappropriate shocks for AF/SVT
timeFrame: 30 days
measure: Percentage of inappropriate shocks for AF/SVT
timeFrame: 1 year
measure: Percentage of inappropriate shocks for AF/SVT
timeFrame: 2 year
Secondary outcomes:
measure: Device related discomfort
timeFrame: 7 days
measure: Device related discomfort
timeFrame: 30 days
measure: Device related discomfort
timeFrame: 1 year
measure: Device related discomfort
timeFrame: 2 year
measure: Efficacy of S-ICD therapy for spontaneous VT/VF
timeFrame: 7 days
measure: Efficacy of S-ICD therapy for spontaneous VT/VF
timeFrame: 30 days
measure: Efficacy of S-ICD therapy for spontaneous VT/VF
timeFrame: 1 year
measure: Efficacy of S-ICD therapy for spontaneous VT/VF
timeFrame: 2 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
References: