Trial Outcomes & Findings for Paracor Ventricular Support System (PVSS) for Patients With Heart Failure (NCT NCT00291551)
NCT ID: NCT00291551
Last Updated: 2012-05-21
Results Overview
TERMINATED
PHASE1
39 participants
6 months
2012-05-21
Participant Flow
12 investigational sites enrolled 39 subjects between January 2005 and October 2006.
Participant milestones
| Measure |
Non-randomized, Single- Arm, Treatment
Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Non-randomized, Single- Arm, Treatment
Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
|
|---|---|
|
Overall Study
Death
|
7
|
|
Overall Study
Withdrawal by Subject
|
6
|
Baseline Characteristics
Paracor Ventricular Support System (PVSS) for Patients With Heart Failure
Baseline characteristics by cohort
| Measure |
Non-randomized, Single- Arm, Treatment
n=39 Participants
Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
|
|---|---|
|
Age Continuous
|
53 years
STANDARD_DEVIATION 11.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Etiology
Ischemic
|
8 participants
n=99 Participants
|
|
Etiology
Non-ischemic
|
31 participants
n=99 Participants
|
|
Duration of heart failure
|
6.9 years
STANDARD_DEVIATION 4.7 • n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Per protocol
Outcome measures
| Measure |
Non-randomized, Single Arm, Treatment
n=39 Participants
|
|---|---|
|
Death or Additional Surgical Session at 6 Months
|
4 participants
|
SECONDARY outcome
Timeframe: 1 dayPopulation: per protocol
"Implant success" refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position.
Outcome measures
| Measure |
Non-randomized, Single Arm, Treatment
n=39 Participants
|
|---|---|
|
Implant Success (Number of Participants Successfully Implanted)
|
38 participants
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: per protocol
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.
Outcome measures
| Measure |
Non-randomized, Single Arm, Treatment
n=36 Participants
|
|---|---|
|
Change in NYHA Functional Class
Improved
|
20 participants
|
|
Change in NYHA Functional Class
Maintained
|
13 participants
|
|
Change in NYHA Functional Class
Worsened
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: per protocol
Mean change in left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) from baseline to 6 months (echocardiographic measurements)
Outcome measures
| Measure |
Non-randomized, Single Arm, Treatment
n=33 Participants
|
|---|---|
|
Changes in Left Ventricular Diameters
LVEDD (cm)
|
-0.3 centimeters
Standard Deviation 0.7
|
|
Changes in Left Ventricular Diameters
LVESD (cm)
|
-0.1 centimeters
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: per protocol
Mean change in left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) from baseline to 6 months (echocardiographic measurements)
Outcome measures
| Measure |
Non-randomized, Single Arm, Treatment
n=35 Participants
|
|---|---|
|
Changes in Left Ventricular Volumes
LVEDV (ml)
|
-31.6 milliliters
Standard Deviation 65.2
|
|
Changes in Left Ventricular Volumes
LVESV (ml)
|
-29.6 milliliters
Standard Deviation 61.6
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: per protocol
Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements)
Outcome measures
| Measure |
Non-randomized, Single Arm, Treatment
n=35 Participants
|
|---|---|
|
Change in Left Ventricular Ejection Fraction
|
1.6 Percentage
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsMean change in left ventricular mass from baseline to 6 months (echocardiogram measurements)
Outcome measures
| Measure |
Non-randomized, Single Arm, Treatment
n=30 Participants
|
|---|---|
|
Change in Left Ventricular Mass
|
-17.6 grams
Standard Deviation 55.3
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: per protocol
Mean change in 6 minute walk distance (meters) between baseline and 6 months
Outcome measures
| Measure |
Non-randomized, Single Arm, Treatment
n=34 Participants
|
|---|---|
|
Changes in 6 Minute Walk
|
71.5 meters
Standard Deviation 122.9
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: per protocol
Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months
Outcome measures
| Measure |
Non-randomized, Single Arm, Treatment
n=32 Participants
|
|---|---|
|
Changes in Cardiopulmonary Tests
|
0 ml/kg/min
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: per protocol
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.
Outcome measures
| Measure |
Non-randomized, Single Arm, Treatment
n=34 Participants
|
|---|---|
|
Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score
|
-15.8 score on a scale
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: Study durationPopulation: per protocol
Total adverse events reported prior to study closure
Outcome measures
| Measure |
Non-randomized, Single Arm, Treatment
n=39 Participants
|
|---|---|
|
Number of Adverse Events
Adverse Events
|
276 events
|
|
Number of Adverse Events
Serious Adverse Events
|
158 events
|
SECONDARY outcome
Timeframe: Study durationPopulation: per protocol
Total number of patient deaths reported prior to study closure
Outcome measures
| Measure |
Non-randomized, Single Arm, Treatment
n=39 Participants
|
|---|---|
|
Number of Participants Who Died
|
7 participants
|
Adverse Events
Non-randomized, Single- Arm, Treatment
Serious adverse events
| Measure |
Non-randomized, Single- Arm, Treatment
n=39 participants at risk
Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
|
|---|---|
|
General disorders
General
|
48.7%
19/39 • Number of events 28 • 6 years, 3 months (maximum)
Patients followed from enrollment until study termination, death, or withdrawal
|
|
Cardiac disorders
Cardiovascular
|
64.1%
25/39 • Number of events 84 • 6 years, 3 months (maximum)
Patients followed from enrollment until study termination, death, or withdrawal
|
|
Gastrointestinal disorders
Gastrointestinal
|
5.1%
2/39 • Number of events 2 • 6 years, 3 months (maximum)
Patients followed from enrollment until study termination, death, or withdrawal
|
|
Renal and urinary disorders
Genital-urinary
|
2.6%
1/39 • Number of events 2 • 6 years, 3 months (maximum)
Patients followed from enrollment until study termination, death, or withdrawal
|
|
Blood and lymphatic system disorders
Hematology
|
10.3%
4/39 • Number of events 5 • 6 years, 3 months (maximum)
Patients followed from enrollment until study termination, death, or withdrawal
|
|
Nervous system disorders
Neurology
|
10.3%
4/39 • Number of events 7 • 6 years, 3 months (maximum)
Patients followed from enrollment until study termination, death, or withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
25.6%
10/39 • Number of events 18 • 6 years, 3 months (maximum)
Patients followed from enrollment until study termination, death, or withdrawal
|
|
Renal and urinary disorders
Renal
|
20.5%
8/39 • Number of events 12 • 6 years, 3 months (maximum)
Patients followed from enrollment until study termination, death, or withdrawal
|
Other adverse events
| Measure |
Non-randomized, Single- Arm, Treatment
n=39 participants at risk
Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
|
|---|---|
|
General disorders
General
|
82.1%
32/39 • Number of events 118 • 6 years, 3 months (maximum)
Patients followed from enrollment until study termination, death, or withdrawal
|
|
Cardiac disorders
Cardiovascular
|
74.4%
29/39 • Number of events 66 • 6 years, 3 months (maximum)
Patients followed from enrollment until study termination, death, or withdrawal
|
|
Gastrointestinal disorders
Gastrointestinal
|
23.1%
9/39 • Number of events 9 • 6 years, 3 months (maximum)
Patients followed from enrollment until study termination, death, or withdrawal
|
|
Renal and urinary disorders
Genital-urinary
|
30.8%
12/39 • Number of events 14 • 6 years, 3 months (maximum)
Patients followed from enrollment until study termination, death, or withdrawal
|
|
Blood and lymphatic system disorders
Hematology
|
10.3%
4/39 • Number of events 6 • 6 years, 3 months (maximum)
Patients followed from enrollment until study termination, death, or withdrawal
|
|
Nervous system disorders
Neurology
|
17.9%
7/39 • Number of events 8 • 6 years, 3 months (maximum)
Patients followed from enrollment until study termination, death, or withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
51.3%
20/39 • Number of events 37 • 6 years, 3 months (maximum)
Patients followed from enrollment until study termination, death, or withdrawal
|
|
Renal and urinary disorders
Renal
|
38.5%
15/39 • Number of events 18 • 6 years, 3 months (maximum)
Patients followed from enrollment until study termination, death, or withdrawal
|
Additional Information
Michael Kolber, General Manager, VP, Regulatory Affairs
Paracor Medical, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place