Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients.

Detailed Description
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The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients. The ability of the diagnostic feature to 'detect' and 'predict' heart failure events will be studied.

Official Title
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Clinical Evaluation of the Physiological Diagnosis Function in the Paradym CRT Device

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Device: Paradym CRT + Physiological Diagnosis (PhD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy Subject has severe heart failure (NYHA Class III or IV) Subject has experienced at least one heart failure event within six months prior to enrollment Subject continues to have heart failure symptoms despite receiving optimal medical therapy Schedule for implant of a PARADYM CRT-D (Model 8770) Subject has signed and dated an informed consent form Exclusion Criteria: Any contraindication for standard cardiac pacing Any contraindication for ICD therapy Abdominal implantation site Hypertrophic or obstructive cardiomyopathy Acute myocarditis 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 (intravenous 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 or HIPAA Unavailability for scheduled follow-up at the implanting center Known sensitivity to 1mg dexamethasone sodium phosphate (DSP) Under guardianship Age of less than 18 years Pregnancy

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRT Therapy<br>All patients will receive CRT therapy with the Physiological Diagnosis (PhD) feature enabled. | Device: Paradym CRT + Physiological Diagnosis (PhD)<br>* All subjects will undergo CRT therapy with the Physiological Diagnosis (PhD) feature enabled.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of diagnostic feature in detecting heart failure events (using the device) in comparison to clinical heart failure events experienced by the patient (as classified by an independent committee). |  | Thirteen months | 
| Mean number of false positives per patient per year. |  | Thirteen Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NYHA Class III or IV, Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy