Randomized Clinical evaluatiON of wireless fluid monitoriNg and rEmote ICD managemenT using OptiVol alert-based predefined management to reduce cardiac decompensation and health care utilization: the CONNECT-OptiVol study

Abstract

Aims: The CONNECT-OptiVol study is designed to investigate whether wireless fluid monitoring using OptiVol alerts as well as implantable cardioverter-defibrillator (ICD) remote monitoring (RM) reduces cardiac decompensations and health care utilization in ICD patients, as compared to standard clinical care.

Methods: Patients undergoing implantation of wireless telemetry-enabled dual chamber (ICD-DR) or cardiac resynchronization therapy/defibrillator (CRT-D) devices with the OptiVol feature are eligible for the study. In a randomized fashion, OptiVol function, its audible alert as well as its remote alert, and other ICD RM alerts are switched ON or OFF. The primary study objective is to estimate an improvement of heart failure status. The primary endpoint is measured as a prolongation of the time to first hospitalization due to worsened heart failure. The secondary objectives are to estimate: a reduction of the time from event to clinical decision, a reduction of the rate of health care utilization, and improved quality of life (QoL) measures (secondary endpoints). The study is designed as a single center pilot study with 180 patients randomized 1:1 to the two study arms.

Conclusion: The CONNECT-OptiVol study aims to answer whether wireless fluid monitoring integrated into RM may reduce cardiac decompensations and health care utilization in ICD patients. The results can be used to adequately power future studies evaluating the benefit of these features. Study enrollment has been completed, and follow-up is expected to be finished in September 2012.

Trial registration: ClinicalTrials.gov NCT00730548.