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

What this Trial Is About

Researchers are studying patients with variant angina who have experienced aborted sudden cardiac death to see if adding an Implantable Cardioverter Defibrillator (ICD) to the best available medical treatment can reduce the chance of death from any cause. This is a phase 4 randomized study comparing ICD implantation plus optimal medical therapy with optimal medical therapy alone. The study aims to understand whether the device can improve survival over standard treatment in these patients. Participants will be randomly assigned to receive either an ICD along with optimal medical therapy or just the optimal medical therapy alone. The ICD is a device implanted to monitor and correct dangerous heart rhythms. All participants will continue their prescribed medical treatments throughout the study. The trial will follow patients for five years to track outcomes related to death and heart events. During the study, participants will be monitored regularly for five years until the last subject completes their final visit. Researchers will check for death from any cause as the primary measure. They will also track other events such as cardiac death, arrhythmia-related death, cardiac arrest, recurrent ventricular tachyarrhythmia, hospitalizations, ICD therapies, device complications, and stroke. Safety and event data will be collected throughout to understand the long-term effects of the treatments.

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