Clinical trial NCT00957541: Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device
Official title: Clinical Evaluation of the Physiological Diagnosis Function in the Paradym CRT Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congestive Heart Failure
Keywords: NYHA Class III or IV
Implantable Cardiac Defibrillator
Cardiac Resynchronization Therapy
Lead sponsor: ELA Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: LivaNova
First posted: 2009-08-12
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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
* 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

Primary outcomes:
measure: 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).
timeFrame: Thirteen months
measure: Mean number of false positives per patient per year.
timeFrame: Thirteen Months
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Mountain Vista Hospital
state: Arizona
Study officials:
References:
citation: Auricchio A, Brugada J, Ellenbogen KA, Gold MR, Leyva F; CLEPSYDRA investigators. Assessment of a novel device-based diagnostic algorithm to monitor patient status in moderate-to-severe heart failure: rationale and design of the CLEPSYDRA study. Eur J Heart Fail. 2010 Dec;12(12):1363-71. doi: 10.1093/eurjhf/hfq170. Epub 2010 Oct 14.