DOT-HF Trial - International trial to determine the diagnostic outcome in Heart Failure

Recruitment & Eligibility

Status: Other (Terminated)

Sex: Not specified

Target Recruitment: 2200

Inclusion Criteria

Subject with left ventricular systolic dysfunction, LVEF ≤ 35%, as documented at the moment of device implant or status as maximal 1 month prior to implant

Subject with a NYHA class II, III or IV, as documented at device implantation

Subject with a history of at least one HF hospitalization, Emergency Department (ED) visit, or urgent office visit necessitating IV diuretic or augmentation of oral diuretic, IV inotropic, or IV vasodilator or other HF parenteral therapy within 12 months prior to device implant

Subject received recently or maximal 6 months before enrollment a CRT, CRT-D or ICD device with OptiVolÂ® Fluid Status Monitoring with Cardiac Compass capability.

Documented evidence must be available to demonstrate that:

- OptiVolÂ® and AT/AF alerts were programmed according nominal settings (OptiVolÂ® alert and AT/AF alerts both turned ?OFF? since implant) and

- Patient management was not influenced by (before randomization) or will not be influenced by reviewing history of the Cardiac Compass reports and

- The SentryCheck? Monitor/PatientLook? Indicator has not been provided to the subject (before randomization)

Subject receiving optimal HF medical therapy including ACE Inhibitor or Angiotensin Receptor Blocker (ARB) and Beta Blocker. If the subject is intolerant of ACE Inhibitors or Beta Blockers, documented evidence must be available. Therapeutic equivalents for ACE Inhibitor substitutions (e.g. ARB) is allowed

Subject is at least 18 years of age (or older if required by local law/regulations)

Subject is willing and able to comply with the Clinical Investigational Plan and willing to remain available for follow-up visits, through study closure

Subject (or if allowed by local law/regulations: subject?s legally authorized representative) is willing and able to sign and date the study Informed Consent

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