Heart Failure, Congestive
Conditions
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.
Interventions
DEVICEPlacement 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.
Sponsors
Paracor Medical, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death or Additional Surgical Session at 6 Months | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| 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 |
| Changes in 6 Minute Walk | Baseline to 6 months | Mean change in 6 minute walk distance (meters) between baseline and 6 months |
Countries
United States
Participant flow
Recruitment details
12 investigational sites enrolled 39 subjects between January 2005 and October 2006.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 7 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Non-randomized, Single- Arm, Treatment |
|---|---|
| Age Continuous | 53 years STANDARD_DEVIATION 11 |
| Duration of heart failure | 6.9 years STANDARD_DEVIATION 4.7 |
| Etiology Ischemic | 8 participants |
| Etiology Non-ischemic | 31 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 39 / 39 |
| serious Total, serious adverse events | 30 / 39 |
Outcome results
Primary
Death or Additional Surgical Session at 6 Months
Time frame: 6 months
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-randomized, Single Arm, Treatment | Death or Additional Surgical Session at 6 Months | 4 participants |
Secondary
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
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-randomized, Single Arm, Treatment | Change in Left Ventricular Ejection Fraction | 1.6 Percentage | Standard Deviation 6 |
Secondary
Change in Left Ventricular Mass
Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements)
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-randomized, Single Arm, Treatment | Change in Left Ventricular Mass | -17.6 grams | Standard Deviation 55.3 |
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.
Time frame: Baseline to 6 months
Population: per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-randomized, Single Arm, Treatment | Change in NYHA Functional Class | Improved | 20 participants |
| Non-randomized, Single Arm, Treatment | Change in NYHA Functional Class | Maintained | 13 participants |
| Non-randomized, Single Arm, Treatment | Change in NYHA Functional Class | Worsened | 3 participants |
Secondary
Changes in 6 Minute Walk
Mean change in 6 minute walk distance (meters) between baseline and 6 months
Time frame: Baseline to 6 months
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-randomized, Single Arm, Treatment | Changes in 6 Minute Walk | 71.5 meters | Standard Deviation 122.9 |
Secondary
Changes in Cardiopulmonary Tests
Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months
Time frame: Baseline to 6 months
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-randomized, Single Arm, Treatment | Changes in Cardiopulmonary Tests | 0 ml/kg/min | Standard Deviation 2.8 |
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)
Time frame: Baseline to 6 months
Population: per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-randomized, Single Arm, Treatment | Changes in Left Ventricular Diameters | LVEDD (cm) | -0.3 centimeters | Standard Deviation 0.7 |
| Non-randomized, Single Arm, Treatment | Changes in Left Ventricular Diameters | LVESD (cm) | -0.1 centimeters | Standard Deviation 0.6 |
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)
Time frame: Baseline to 6 months
Population: per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-randomized, Single Arm, Treatment | Changes in Left Ventricular Volumes | LVEDV (ml) | -31.6 milliliters | Standard Deviation 65.2 |
| Non-randomized, Single Arm, Treatment | Changes in Left Ventricular Volumes | LVESV (ml) | -29.6 milliliters | Standard Deviation 61.6 |
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.
Time frame: 1 day
Population: per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-randomized, Single Arm, Treatment | Implant Success (Number of Participants Successfully Implanted) | 38 participants |
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.
Time frame: Baseline to 6 months
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-randomized, Single Arm, Treatment | 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
Number of Adverse Events
Total adverse events reported prior to study closure
Time frame: Study duration
Population: per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-randomized, Single Arm, Treatment | Number of Adverse Events | Adverse Events | 276 events |
| Non-randomized, Single Arm, Treatment | Number of Adverse Events | Serious Adverse Events | 158 events |
Secondary
Number of Participants Who Died
Total number of patient deaths reported prior to study closure
Time frame: Study duration
Population: per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-randomized, Single Arm, Treatment | Number of Participants Who Died | 7 participants |