Diagnostic Outcome Trial in Heart Failure (DOT-HF Trial)

Study Overview
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Brief Summary
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The DOT-HF trial is an international, prospective, multi-center, randomized, controlled trial.

Detailed Description
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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)

Official Title
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Diagnostic Outcome Trial in Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of both genders with mild to severe HF as defined as NHYA Class II to IV who also have an indication for device implant according to ESC/AHA guidelines as well as having a HF hospitalization or Emergency Department visit necessitating therapy within the past 12 months and who meet all inclusion criteria and no exclusion criteria, are eligible for this study. Exclusion Criteria: Subject is post heart transplant or actively listed on the transplant list and reasonable probability (as defined by investigator) of undergoing transplantation in the next year Subject received a coronary artery bypass graft or valve surgery in last 90 days Subject with a myocardial infarction (MI) in the last 40 days. Subject's life expectancy is less than one year in the opinion of the physician Subject has severe Chronic Obstructive Pulmonary Disease (COPD), as determined by physician and documented in medical records Subject is listed for valve replacement/valve repair Subject has severe, primary pulmonary hypertension as determined by physician and documented in medical records Subject with serum creatinine ≥ 2.5 mg/dL measured within 14 days prior to enrolment Subject on chronic renal dialysis Subject on continuous or uninterrupted (≥ 2 stable infusions per week) infusion (inotropic) therapy for HF Subject has complex and uncorrected Congenital Heart Disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention: in the access arm the patiens had programmmed the audible OptiVol Fliud status alert on. Control patienst had programmed the audible alert off
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Access Arm<br>HF subjects managed with standard clinical assessment and using the audible OptiVol® Fluid status monitoring alert and the device Cardiac Compass Report | Device: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )<br>* OptiVol® Fluid status Monitoring with Cardiac Compass<br>* Other names: OptiVol® audible alert;|
| Active Comparator: Control arm<br>HF subjects managed with standard clinical assessment | Device: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )<br>* OptiVol® Fluid status Monitoring with Cardiac Compass<br>* Other names: OptiVol® audible alert;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 14.9 ± 5.4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, randomized, OptiVol® Fluid status monitoring