Status:
COMPLETED
Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device
Lead Sponsor:
ELA Medical, Inc.
Collaborating Sponsors:
LivaNova
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT00957541
Start Date
September 1 2009
End Date
April 1 2013
Last Update
May 15 2014
Active Locations (1)
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1
Mountain Vista Hospital
Mesa, Arizona, United States, 85209