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Prospective Clinical Registry of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (S-ICD Korea Registry)

13. oktober 2019 oppdatert av: Yonsei University

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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

300

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Boyoung Jung
Telefonnummer: +82 02-2228-8447
E-post: cby6908@yuhs.ac

Studiesteder

Korea, Republikken
- - Seoul, Korea, Republikken, 03722
    - Rekruttering
    - Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
    - Ta kontakt med:
      
      Boyoung Joung, M.D., Ph.D.
      
      Telefonnummer: +82-2228-8447
      
      E-post: CBY690@yuhs.ac

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

19 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

patients who have received the EMBLEM S-ICD system

Beskrivelse

Inclusion Criteria:

> 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 Criteria:

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
S-ICD patients patients who have received the EMBLEM S-ICD system

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
Perioperative S-ICD Complication Free Rate up to 7 days post implant Tidsramme: 7 days	7 days
Perioperative S-ICD Complication Free Rate up to 30 days post implant Tidsramme: 30 days	30 days
1 year S-ICD Complication Free Rate Tidsramme: 1 year	1 year
2 year S-ICD Complication Free Rate Tidsramme: 2 year	2 year
Percentage of inappropriate shocks for AF/SVT Tidsramme: 7 days	7 days
Percentage of inappropriate shocks for AF/SVT Tidsramme: 30 days	30 days
Percentage of inappropriate shocks for AF/SVT Tidsramme: 1 year	1 year
Percentage of inappropriate shocks for AF/SVT Tidsramme: 2 year	2 year

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Device related discomfort Tidsramme: 7 days	Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.	7 days
Device related discomfort Tidsramme: 30 days	Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.	30 days
Device related discomfort Tidsramme: 1 year	Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.	1 year
Device related discomfort Tidsramme: 2 year	Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.	2 year
Efficacy of S-ICD therapy for spontaneous VT/VF Tidsramme: 7 days	Efficacy of S-ICD therapy for spontaneous VT/VF means the successful termination of spontaneous VT/VF by the shock delivered by S-ICD therapy.	7 days
Efficacy of S-ICD therapy for spontaneous VT/VF Tidsramme: 30 days	Efficacy of S-ICD therapy for spontaneous VT/VF means the successful termination of spontaneous VT/VF by the shock delivered by S-ICD therapy.	30 days
Efficacy of S-ICD therapy for spontaneous VT/VF Tidsramme: 1 year	Efficacy of S-ICD therapy for spontaneous VT/VF means the successful termination of spontaneous VT/VF by the shock delivered by S-ICD therapy.	1 year
Efficacy of S-ICD therapy for spontaneous VT/VF Tidsramme: 2 year	Efficacy of S-ICD therapy for spontaneous VT/VF means the successful termination of spontaneous VT/VF by the shock delivered by S-ICD therapy.	2 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Yonsei University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. mai 2019

Primær fullføring (Forventet)

1. oktober 2022

Studiet fullført (Forventet)

1. april 2024

Datoer for studieregistrering

Først innsendt

8. oktober 2019

Først innsendt som oppfylte QC-kriteriene

13. oktober 2019

Først lagt ut (Faktiske)

15. oktober 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)