The DOT-HF trial is an international, prospective, multi-center, randomized, controlled trial.
The study was designed with a Control Arm in order to adequately study the effect of early intervention triggered by the OptiVol® Alert and/or SentryCheck™ Monitor/PatientLook™ Indicator and evaluation using OptiVol® Fluid Status Monitoring with Cardiac Compass. OptiVol® Fluid Status Monitoring with Cardiac Compass features are available in the per Clinical Investigational Plan specified Medtronic products (CRT, CRT-D and ICD devices)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
335
OptiVol® Fluid status Monitoring with Cardiac Compass
Medtronic Bakken Research Center
Maastricht, Netherlands
Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization
Number of participants with a combined end point of all-cause mortality or heart failure hospitalization
Time frame: 14.9 ± 5.4 months
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