Comparing Implantable Cardioverter Defibrillator and Optimal Medical Therapy in Adults with Variant Angina and Aborted Sudden Cardiac Death

What this Trial Is About

Researchers are evaluating whether adding an Implantable Cardioverter Defibrillator ICD to optimal medical therapy reduces the overall death rate in patients with variant angina who have survived sudden cardiac arrest. This trial focuses on patients diagnosed with variant angina characterized by coronary spasms and who have experienced aborted sudden cardiac death. The study is a phase 4, randomized trial comparing ICD implantation plus medical therapy versus medical therapy alone. Participants are assigned to either receive an ICD implanted along with optimal medical therapy or continue with optimal medical therapy alone. The trial monitors participants for five years, tracking the occurrence of deaths and other cardiac-related events. Assessments include event rates of cardiac death, arrhythmia-related death, cardiac arrest, ventricular tachyarrhythmia recurrence, hospitalizations, ICD therapies, device complications, and strokes. Throughout the study, participants undergo regular monitoring over five years until the last participants final visit. Researchers collect data on survival and cardiac events to determine the effectiveness of ICD implantation alongside medical therapy. The total duration of participation is up to five years, with ongoing safety and event monitoring to capture detailed outcome information.

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