NCT02845531

Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Kee-joon Choi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether ICD(Implantable Cardioverter Defibrillator) implantation on the top of optimal medical therapy in patients with variant angina manifesting as aborted sudden cardiac death reduces the incidence of the death from any cause compared with optimal medical therapy alone.

Detailed description

All participants will be monitored over a span of five years and the time point of the year of last subject last visit. The term "year of last subject last visit" refers to the time point of the last visit for all participants. At this specific time point, event occurrence check will be conducted to determine the occurrence of endpoint events among all participants.

Conditions

• Angina Pectoris, Variant
• Sudden Cardiac Death

Interventions

Type	Name	Description
DEVICE	Implantable Cardioverter Defibrillator	Implantable Cardioverter Defibrillator and Optimal Medical Therapy
DRUG	Optimal Medical Therapy

Timeline

• Start date: 2016-11-29
• Primary completion: 2030-12-01
• Completion: 2031-06-01
• First posted: 2016-07-27
• Last updated: 2025-06-15

Locations

25 sites across 1 country: South Korea