Project Summary

The implantable cardioverter defibrillator (ICD) is placed inside the heart of patients with risk of sudden death and can terminate a life-threatening heart rhythm disturbance by delivery of therapy or shock to the patient. Currently, there is a recommendation to place an ICD for the prevention of sudden cardiac death inside the heart chambers of patients who have heart failure and a low cardiac function, even if they did not experience any heart rhythm disturbance in the past and even if their risk for sudden death is low. This recommendation is based on studies that were performed more than 20 years ago that may not be applicable to contemporary patients with heart failure. 

Better medications are available to treat heart failure and prevent sudden cardiac death, even without the need to place an ICD inside the heart of patients with heart failure. ICDs may cause complication, such as systemic infections and inappropriate delivery of shock to patients that may increase anxiety and reduce quality of life of patients who are living with heart failure. Thus, there is an unmet need for more appropriate selection of patients who will benefit from ICD implantation, due to its potential risks and associated complications. 

Supported by heart failure and electrophysiology leaders and societies, this study will conduct the first randomized clinical trial to assess the benefit and risks of implanting an ICD in patients with heart failure who have a low risk of sudden death. 

The CONTEMP-ICD (Comparative Effectiveness of ICD Versus Non-ICD Therapy in Contemporary Heart Failure Patients With a Low Risk for Arrhythmic Death) study is a prospective, multicenter, open-label, randomized-controlled trial enrolling 2,740 participants with heart failure who are treated with optimal stable medical therapy and are eligible for an ICD based on current recommendations, but have a lower predicted risk of heart rhythm disturbances and sudden death. 

Enrolled participants will be randomized to no-ICD versus ICD treatment arms. The research team hypothesizes that, in patients with heart failure who are at a lower predicted risk of sudden death, ICD will not be better than no-ICD therapy for the prevention of death. Researchers also hypothesize that patients treated without an ICD will have a lower risk of cardiovascular complications and hospitalizations, improved quality of life, and improved utilization of healthcare resources, compared to patients who will receive an ICD. 

The study team believes findings from this study will result in a paradigm change in heart failure management, shifting healthcare resources from unnecessary routine ICD placement to more appropriate heart failure management that actively incorporates contemporary medical therapy with personalized selection for implantable device therapy.

Project Information

Ilan Goldenberg, M.D.
Wojciech Zareba, M.D.
University of Rochester
$27,252,903 *

Key Dates

78 months *
April 2024
2024

*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.

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Last updated: April 23, 2024