Trial design of the clinical evaluation of remote notification to reduce time to clinical decision: The Clinical evaluation Of remote NotificatioN to rEduCe Time to clinical decision (CONNECT) study

Abstract

Indications for implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators have greatly expanded in the last 5 years, encompassing a wider variety of patients with a multitude of comorbidities. To meet the needs of these patients, the managing clinicians need to streamline their follow-up care. New ICD/cardiac resynchronization therapy defibrillators provide enhanced device status and disease progression remote monitoring capabilities that support more comprehensive and efficient follow-ups. In addition, this monitoring between follow-ups is likely to impact health care utilization. The Clinical evaluation Of remote NotificatioN to rEduCe Time to clinical decision (CONNECT) study will randomize approximately 2,000 patients implanted with an ICD with or without CRT capabilities from 150 sites in the United States to remote monitoring versus standard in-office care. This study will evaluate the time from clinical event to clinical decision in response to the event, as well as the associated impact on health care utilization and quality of life. Patients monitored remotely will be provided a home monitor for transmitting device diagnostics to the clinician's office. These devices will use wireless telemetry, allowing the automatic transmission of diagnostics to the office without the need for patient intervention. Patients receiving in-office care will be followed in the office at a fixed schedule and without remote monitoring. All patients will be followed for 15 months postimplant. The CONNECT study is evaluating the impact of remote monitoring and early notification using wireless telemetry on the time to clinical decisions, the allocation of health care utilization, and quality of life. Results from this study are expected mid-2009.