A Phase 1 interventional study of Placement of the PVSS Implant in Heart Failure, Congestive, sponsored by Paracor Medical, Inc. Terminated at 12 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-05-21.
Sponsored by Paracor Medical, Inc · Phase 1, Interventional, and Treatment
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.
Please refer to brief summary.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 39 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Paracor Medical, Inc is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Implant is placed on epicardial surface of the heart surrounding both the right and left ventricles, to provide mechanical support to the ventricular walls.
Also known as: HeartNet, Ventricular support device, Ventricular elastic support therapy
Death or Additional Surgical Session at 6 Months
Time frame: 6 months
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.
Time frame: 1 day
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.
Time frame: Baseline to 6 months
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)
Time frame: Baseline to 6 months
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)
Time frame: Baseline to 6 months
Change in Left Ventricular Ejection Fraction
Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements)
Time frame: Baseline to 6 months
Change in Left Ventricular Mass
Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements)
Time frame: Baseline to 6 months
Changes in 6 Minute Walk
Mean change in 6 minute walk distance (meters) between baseline and 6 months
Time frame: Baseline to 6 months
Changes in Cardiopulmonary Tests
Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months
Time frame: Baseline to 6 months
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.
Time frame: Baseline to 6 months
Number of Adverse Events
Total adverse events reported prior to study closure
Time frame: Study duration
Number of Participants Who Died
Total number of patient deaths reported prior to study closure
Time frame: Study duration
12 investigational sites enrolled 39 subjects between January 2005 and October 2006.
| Milestone | Non-randomized, Single- Arm, Treatment |
|---|---|
| Started | 39 |
| Completed | 26 |
| Not completed | 13 |
| Withdrew: Death | 7 |
| Withdrew: Withdrawal by subject | 6 |
| participants | Non-randomized, Single Arm, Treatment |
|---|---|
| Death or Additional Surgical Session at 6 Months | 4 |
"Implant success" refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position.
| participants | Non-randomized, Single- Arm, Treatment |
|---|---|
| Implant Success (Number of Participants Successfully Implanted) | 38 |
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.
| participants | Non-randomized, Single- Arm, Treatment |
|---|---|
| Improved | 20 |
| Maintained | 13 |
| Worsened | 3 |
Mean change in left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) from baseline to 6 months (echocardiographic measurements)
| centimeters | Non-randomized, Single- Arm, Treatment |
|---|---|
| LVEDD (cm) | -0.3 ± 0.7 |
| LVESD (cm) | -0.1 ± 0.6 |
Mean change in left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) from baseline to 6 months (echocardiographic measurements)
| milliliters | Non-randomized, Single Arm, Treatment |
|---|---|
| LVEDV (ml) | -31.6 ± 65.2 |
| LVESV (ml) | -29.6 ± 61.6 |
Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements)
| Percentage | Non-randomized, Single Arm, Treatment |
|---|---|
| Change in Left Ventricular Ejection Fraction | 1.6 ± 6.0 |
Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements)
| grams | Non-randomized, Single Arm, Treatment |
|---|---|
| Change in Left Ventricular Mass | -17.6 ± 55.3 |
Mean change in 6 minute walk distance (meters) between baseline and 6 months
| meters | Non-randomized, Single- Arm, Treatment |
|---|---|
| Changes in 6 Minute Walk | 71.5 ± 122.9 |
Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months
| ml/kg/min | Non-randomized, Single- Arm, Treatment |
|---|---|
| Changes in Cardiopulmonary Tests | 0 ± 2.8 |
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.
| score on a scale | Non-randomized, Single- Arm, Treatment |
|---|---|
| Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score | -15.8 ± 22.2 |
Total adverse events reported prior to study closure
| events | Non-randomized, Single- Arm, Treatment |
|---|---|
| Adverse Events | 276 |
| Serious Adverse Events | 158 |
Total number of patient deaths reported prior to study closure
| participants | Non-randomized, Single- Arm, Treatment |
|---|---|
| Number of Participants Who Died | 7 |
Collected over 6 years, 3 months (maximum). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non-randomized, Single- Arm, Treatment | — | 30/39 (76.9%) | 39/39 (100%) |
| Event | Non-randomized, Single- Arm, Treatment |
|---|---|
| CardiovascularCardiac disorders | 25/39 |
| GeneralGeneral disorders | 19/39 |
| PulmonaryRespiratory, thoracic and mediastinal disorders | 10/39 |
| RenalRenal and urinary disorders | 8/39 |
| HematologyBlood and lymphatic system disorders | 4/39 |
| NeurologyNervous system disorders | 4/39 |
| GastrointestinalGastrointestinal disorders | 2/39 |
| Genital-urinaryRenal and urinary disorders | 1/39 |
| Event | Non-randomized, Single- Arm, Treatment |
|---|---|
| GeneralGeneral disorders | 32/39 |
| CardiovascularCardiac disorders | 29/39 |
| PulmonaryRespiratory, thoracic and mediastinal disorders | 20/39 |
| RenalRenal and urinary disorders | 15/39 |
| Genital-urinaryRenal and urinary disorders | 12/39 |
| GastrointestinalGastrointestinal disorders | 9/39 |
| NeurologyNervous system disorders | 7/39 |
| HematologyBlood and lymphatic system disorders | 4/39 |
| Age Continuous(years) | Non-randomized, Single- Arm, Treatment |
|---|---|
| Mean | 53 ± 11.0 |
| Sex: Female, Male(Participants) | Non-randomized, Single- Arm, Treatment |
|---|---|
| Female | 3 |
| Male | 36 |
| Race (NIH/OMB)(Participants) | Non-randomized, Single- Arm, Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 35 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Etiology(participants) | Non-randomized, Single- Arm, Treatment |
|---|---|
| Ischemic | 8 |
| Non-ischemic | 31 |
| Duration of heart failure(years) | Non-randomized, Single- Arm, Treatment |
|---|---|
| Mean | 6.9 ± 4.7 |
This study is terminated, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Paracor Medical, Inc