Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device (CLEPSYDRA)
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This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD).
Condition or disease
Device: Paradym CRT 8770
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, physiological Diagnostic (PhD)which as been implemented in the PARADYM CRT Cardiac Resynchronization System with defibrillation capabalities (PARADYM CRT System,model 8770.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patient eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy
Severe HF (NYHA Class III or IV) at the time of enrollment
At least one HF-related event (as defined for primary objective) within the last 6 months before enrolment
Subject continues to have heart failure symptoms despite receiving optimal medical therapy consistent with current practice guidelines for the pharmacological management of heart failure
Scheduled for implant of a PARADYM 8770
Signed and dated informed consent
Any contraindication for standard cardiac pacing
Any contraindication for ICD therapy
Abdominal implantation side
Hypertrophic or obstructive cardiomyopathy
Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
Recent (within the last month) or planned cardiac revascularization or coronary angioplasty
Correctable valvular disease that is the primary cause of heart failure
Mechanical tricuspid valve
Receiving continuous intra-venous infusion of positive inotropic therapy or intermittent therapy (intra-venous infusion) more than twice per week
Heart transplant recipient
Renal insufficiency requiring dialysis
Already included in another clinical study
Life expectancy less than 12 months
Inability to understand the purpose of the study or refusal to cooperate
Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization
Unavailability for scheduled follow-up at the implanting center
Known sensitivity to 1 mg dexamethasone sodium phosphate (DSP)
Age of less than 18 years
Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)