Left Sided Heart Failure
Conditions
Brief summary
This is a prospective, multi-center,single-arm study that will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs®) protocol and database. All participating centers are current INTERMACS® sites in good standing and follow the INTERMACS® protocol and procedures.
Interventions
DEVICEHeartWare HVAD
Implant of HeartWare HVAD via thoracotomy implant technique
PROCEDUREThoracotomy
Thoracotomy implant technique
Sponsors
INTERMACS
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must be ≥19 years of age at time of informed consent to participate in the Intermacs® registry. 2. Subject receives a HeartWare HVAD (The device should be the subject's first VAD implant). 3. Subject signed an Intermacs® informed consent if required by local IRB policy. 4. Subject signed a HeartWare informed consent.
Exclusion criteria
1. Subject is incarcerated (prisoner). 2. Subject did not sign the informed consent at sites where waiver of consent was not granted. 3. Body Surface Area (BSA) \< 1.2 m\^2. 4. Prior cardiac transplant or cardiomyoplasty. 5. Subject is receiving a BiVAD. 6. Subject is receiving the device as an RVAD. 7. Subject data is generated from non- Intermacs® centers. 8. Pediatric subjects (\< 19 years of age). 9. Subjects who receive a temporary LVAD 10. Subjects whose device strategy is listed as Destination Therapy at the time of implant. 11. Severe Right Heart failure 12. Aortic insufficiency or mechanical aortic valve. 13. Planned concomitant procedure (e.g.valve repair or replacement, CABG, septal defect repair). 14. Known LV Thrombus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months | 6 months | * Alive on the originally implanted device at six months, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event); or * Transplanted by Month 6, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event); or * Explanted for recovery by Month 6, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Length of Initial Hospital Stay | Initial Hospital Stay | Mean length of initial hospital stay including both acute care (ICU/CCU) and step-down Care time |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Per Protocol Population Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy. | 144 |
| Total | 144 |
Baseline characteristics
| Characteristic | Per Protocol Population |
|---|---|
| Age, Continuous | 54.2 years STANDARD_DEVIATION 11.5 |
| Body Mass Index | 27.1 kilograms per meters squared STANDARD_DEVIATION 5.1 |
| Body Surface Area | 2.0 meters squared STANDARD_DEVIATION 0.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 132 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Height | 175.2 centimeters STANDARD_DEVIATION 8.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 90 Participants |
| Region of Enrollment Canada | 3 participants |
| Region of Enrollment United States | 141 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 111 Participants |
| Weight | 83.5 kilograms STANDARD_DEVIATION 18.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 20 / 144 |
| other Total, other adverse events | 44 / 144 |
| serious Total, serious adverse events | 134 / 144 |
Outcome results
Primary
Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months
* Alive on the originally implanted device at six months, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event); or * Transplanted by Month 6, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event); or * Explanted for recovery by Month 6, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event).
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Per Protocol Population | Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months | 128 Participants |
Comparison: Success at six months is estimated to be 86% compared to a performance goal of 77.5%. Using an exact binomial test, with a one-sided alpha of 0.05, and 80% Power, a sample size of 145 implanted subjects was planned.~Success will be met if the lower bound of the upper one-sided exact 95% confidence interval is greater than 77.5%.p-value: 0.0003Exact Binomial
Secondary
Mean Length of Initial Hospital Stay
Mean length of initial hospital stay including both acute care (ICU/CCU) and step-down Care time
Time frame: Initial Hospital Stay
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Per Protocol Population | Mean Length of Initial Hospital Stay | 17.8 days | Standard Deviation 11.7 |
Comparison: The secondary endpoint is an improvement in the mean length of initial hospital stay (initial recovery and step down unit), which is calculated by considering the number of days in acute care (ICU/CCU) plus the number of days in intermediate/step-down care, comprising the total number of days post-implant to discharge.~This secondary endpoint will be calculated using an upper tail one-sided t-test at 0.05 level of significance compared to 26.1 days for median sternotomy patients.p-value: <0.0001t-test, 1 sided