Congestive Heart Failure
Conditions
Keywords
NYHA Class III or IV, Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy
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.
Interventions
DEVICEParadym CRT + Physiological Diagnosis (PhD)
All subjects will undergo CRT therapy with the Physiological Diagnosis (PhD) feature enabled.
Sponsors
LivaNova
ELA Medical, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed