Clinical trial NCT00291551: Paracor Ventricular Support System (PVSS) for Patients With Heart Failure
Official title: Paracor Ventricular Support System: United States Clinical Investigational Plan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Heart Failure, Congestive
Lead sponsor: Paracor Medical, Inc
Sponsor class: INDUSTRY
First posted: 2006-02-14
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* NYHA functional class II or III
* Best medical therapy
* Ejection fraction \<= 35%

Exclusion Criteria:

* 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

Primary outcomes:
measure: Death or Additional Surgical Session at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Implant Success (Number of Participants Successfully Implanted)
timeFrame: 1 day
measure: Change in NYHA Functional Class
timeFrame: Baseline to 6 months
measure: Changes in Left Ventricular Diameters
timeFrame: Baseline to 6 months
measure: Changes in Left Ventricular Volumes
timeFrame: Baseline to 6 months
measure: Change in Left Ventricular Ejection Fraction
timeFrame: Baseline to 6 months
measure: Change in Left Ventricular Mass
timeFrame: Baseline to 6 months
measure: Changes in 6 Minute Walk
timeFrame: Baseline to 6 months
measure: Changes in Cardiopulmonary Tests
timeFrame: Baseline to 6 months
measure: Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score
timeFrame: Baseline to 6 months
measure: Number of Adverse Events
timeFrame: Study duration
measure: Number of Participants Who Died
timeFrame: Study duration
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, Division of Cardiovascular Disease
state: Alabama
city: Denver
country: United States
facility: University of Colorado, Health Sciences Center
state: Colorado
city: Gainesville
country: United States
facility: University of Florida, Division of Cardiology
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
city: Kansas City
country: United States
facility: Mid America Heart Institute
state: Missouri
city: Lincoln
country: United States
facility: BryanLGH Heart Institute
state: Nebraska
city: Columbus
country: United States
facility: The Ohio State University Heart Center
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
Study officials:
affiliation: Ohio State University
name: William T Abraham, MD
role: PRINCIPAL_INVESTIGATOR
References: