Clinical Evaluation of the Physiological Diagnosis Function in the Paradym CRT Device
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Congestive Heart Failure
- Sponsor
- ELA Medical, Inc.
- Enrollment
- 520
- Locations
- 1
- Primary Endpoint
- 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).
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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).
Time Frame: Thirteen months
Mean number of false positives per patient per year.
Time Frame: Thirteen Months