Paracor Ventricular Support System (PVSS) for Patients With Heart Failure
- Conditions
- Heart Failure, Congestive
- Registration Number
- NCT00291551
- Lead Sponsor
- Paracor Medical, Inc
- Brief Summary
This is a limited safety and feasibility study to evaluate the PVSS Introducer and Paracor Ventricular Support System when used to treat patients with heart failure. The implant, which is loaded onto the delivery system, is placed over the epicardial surface of the right and left ventricles.
No formal hypothesis testing will be performed; descriptive statistics will be used to summarize patient outcomes. The results of the study will be used to guide the design and sample size estimation of future studies.
- Detailed Description
Please refer to brief summary.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 39
- NYHA functional class II or III
- Best medical therapy
- Ejection fraction <= 35%
- Heart measurements too large or small for implant sizes
- Intra-cardiac thrombus
- Restrictive cardiomyopathy
- Not a candidate for sternotomy
- Expected adhesions
- Previous coronary artery bypass graft (CABG)
- Active infection
- Stroke, surgery, or implantable cardioverter defibrillator (ICD) within 3 months
- Myocardial infarction (MI) within 1 month
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Death or Additional Surgical Session at 6 Months 6 months
- Secondary Outcome Measures
Name Time Method Implant Success (Number of Participants Successfully Implanted) 1 day "Implant success" refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position.
Change in NYHA Functional Class Baseline to 6 months Change in NYHA functional class between baseline and 6 months. "Maintained" means the participant's functional class remains the same as baseline. "Improved" means the participant's functional class has improved (become lower in number) by at least one class. "Worsened" means the participatn's functional class has deteriorated (become higher in number) by at least one class.
Changes in Left Ventricular Diameters Baseline to 6 months Mean change in left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) from baseline to 6 months (echocardiographic measurements)
Changes in Left Ventricular Volumes Baseline to 6 months Mean change in left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) from baseline to 6 months (echocardiographic measurements)
Change in Left Ventricular Ejection Fraction Baseline to 6 months Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements)
Change in Left Ventricular Mass Baseline to 6 months Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements)
Changes in 6 Minute Walk Baseline to 6 months Mean change in 6 minute walk distance (meters) between baseline and 6 months
Changes in Cardiopulmonary Tests Baseline to 6 months Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months
Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score Baseline to 6 months The MLHF Quality of Life (QOL) Questionnaire evaluates the effects of heart failure on a subject's physical, emotional, social and mental dimensions of quality of life. Each of 21 questions is scored as to how much heart failure has impacted the subject, from 0-no impact to 5-very much (overall score can range from 0 to 105). Prior studies have shown a 10-point improvement (10-point decrease in overall score) correlated with a 1 NYHA class improvement, and 10-point worsening (10-point increase in score) was associated with a higher risk of hospitalization or death.
Number of Adverse Events Study duration Total adverse events reported prior to study closure
Number of Participants Who Died Study duration Total number of patient deaths reported prior to study closure
Trial Locations
- Locations (12)
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
University of Alabama at Birmingham, Division of Cardiovascular Disease
🇺🇸Birmingham, Alabama, United States
University of Florida, Division of Cardiology
🇺🇸Gainesville, Florida, United States
University of Colorado, Health Sciences Center
🇺🇸Denver, Colorado, United States
BryanLGH Heart Institute
🇺🇸Lincoln, Nebraska, United States
Mid America Heart Institute
🇺🇸Kansas City, Missouri, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Minneapolis VA Medical Center
🇺🇸Minneapolis, Minnesota, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
The Ohio State University Heart Center
🇺🇸Columbus, Ohio, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States