Paracor Ventricular Support System (PVSS) for Patients With Heart Failure

Heart Failure, Congestive Clinical Trial

— PEERLESS-HF  

Official title:

Paracor Ventricular Support System: United States Clinical Investigational Plan

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00291551
• Other study ID #: 102.1
• Status: Terminated
• Phase: Phase 1
• First received: February 10, 2006
• Last updated: May 14, 2012
• Start date: January 2005
• Est. completion date: April 2011

Study information

• Verified date: May 2012
• Source: Paracor Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Please refer to brief summary.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: April 2011
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Device:
• Placement of the PVSS Implant
Implant is placed on epicardial surface of the heart surrounding both the right and left ventricles, to provide mechanical support to the ventricular walls.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of Alabama at Birmingham, Division of Cardiovascular Disease	Birmingham	Alabama
United States	The Ohio State University Heart Center	Columbus	Ohio
United States	University of Colorado, Health Sciences Center	Denver	Colorado
United States	University of Florida, Division of Cardiology	Gainesville	Florida
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	The Methodist Hospital	Houston	Texas
United States	Mid America Heart Institute	Kansas City	Missouri
United States	BryanLGH Heart Institute	Lincoln	Nebraska
United States	Minneapolis VA Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Paracor Medical, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death or Additional Surgical Session at 6 Months		6 months	Yes
Secondary	Implant Success (Number of Participants Successfully Implanted)	"Implant success" refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position.	1 day	No
Secondary	Change in NYHA Functional Class	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.	Baseline to 6 months	No
Secondary	Changes in Left Ventricular Diameters	Mean change in left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) from baseline to 6 months (echocardiographic measurements)	Baseline to 6 months	No
Secondary	Changes in Left Ventricular Volumes	Mean change in left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) from baseline to 6 months (echocardiographic measurements)	Baseline to 6 months	No
Secondary	Change in Left Ventricular Ejection Fraction	Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements)	Baseline to 6 months	No
Secondary	Change in Left Ventricular Mass	Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements)	Baseline to 6 months	No
Secondary	Changes in 6 Minute Walk	Mean change in 6 minute walk distance (meters) between baseline and 6 months	Baseline to 6 months	No
Secondary	Changes in Cardiopulmonary Tests	Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months	Baseline to 6 months	No
Secondary	Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score	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.	Baseline to 6 months	No
Secondary	Number of Adverse Events	Total adverse events reported prior to study closure	Study duration	Yes
Secondary	Number of Participants Who Died	Total number of patient deaths reported prior to study closure	Study duration	Yes