Trial Outcomes & Findings for CentriMag RVAS U.S. Post-approval Study Protocol (NCT NCT01568424)
NCT ID: NCT01568424
Last Updated: 2022-06-27
Results Overview
In patients who recover and do not go on to transplantation or a long-term device: Survival to 30 days post-support or to hospital discharge (whichever is longer). In patients who do not recover and are bridged to transplant or a long-term system: Survival to induction of anesthesia for implantation of a long-term device or heart transplant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
30 days post device removal
Results posted on
2022-06-27
Participant Flow
This study included data from 25 consecutive patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life. All patients implanted with a CentriMag RVAS were approached for enrollment.
Participant milestones
| Measure |
Treatment Group
Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CentriMag RVAS U.S. Post-approval Study Protocol
Baseline characteristics by cohort
| Measure |
Treatment Group
n=25 Participants
Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS
|
|---|---|
|
Age, Continuous
|
53 Years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Cardiac Index (CI)
|
2.4 L/min/m^2
n=5 Participants
|
|
Mean Arterial Pressure (MAP)
|
72 mmHg
n=5 Participants
|
|
Central Venous Pressure (CVP)
|
11 mmHg
n=5 Participants
|
|
Blood Urea Nitrogen (BUN)
|
27 mg/dl
n=5 Participants
|
|
Creatinine (mg/dl)
|
1.4 mg/dl
n=5 Participants
|
|
Total Bilirubin (mg/dl)
|
1.1 mg/dl
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days post device removalIn patients who recover and do not go on to transplantation or a long-term device: Survival to 30 days post-support or to hospital discharge (whichever is longer). In patients who do not recover and are bridged to transplant or a long-term system: Survival to induction of anesthesia for implantation of a long-term device or heart transplant.
Outcome measures
| Measure |
Treatment Group
n=25 Participants
Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS
|
|---|---|
|
Survival
|
80 percentage of survival at 30 days
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removalPopulation: Patients with continuous RVAD support.
CVP is a measure of right heart filling pressure, or the preload to the right ventricle. During RVAD support, the CVP decreases as blood is drawn into the pump and then ejected into the pulmonary artery.
Outcome measures
| Measure |
Treatment Group
n=23 Participants
Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS
|
|---|---|
|
Central Venous Pressure (CVP)
Baseline
|
11 mmHg
Interval 4.0 to 22.0
|
|
Central Venous Pressure (CVP)
Day 1
|
11 mmHg
Interval 2.0 to 20.0
|
|
Central Venous Pressure (CVP)
Day 2
|
10 mmHg
Interval 6.0 to 24.0
|
|
Central Venous Pressure (CVP)
Day 3
|
12 mmHg
Interval 0.0 to 17.0
|
|
Central Venous Pressure (CVP)
Week 1
|
11 mmHg
Interval 0.0 to 16.0
|
|
Central Venous Pressure (CVP)
Prior to explant
|
10 mmHg
Interval 5.0 to 18.0
|
|
Central Venous Pressure (CVP)
Post pump day 1
|
12 mmHg
Interval 6.0 to 18.0
|
|
Central Venous Pressure (CVP)
Post pump day 2
|
11 mmHg
Interval 6.0 to 18.0
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal.Population: Patients with continuous RVAD support.
MAP is the mean value for the blood pressure in the arterial circulation. During RVAD support, this value provides information regarding the adequacy of cardiac output from the left ventricle.
Outcome measures
| Measure |
Treatment Group
n=22 Participants
Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS
|
|---|---|
|
Mean Arterial Pressure (MAP)
Baseline
|
72 mmHg
Interval 59.0 to 106.0
|
|
Mean Arterial Pressure (MAP)
Day 1
|
74 mmHg
Interval 62.0 to 97.0
|
|
Mean Arterial Pressure (MAP)
Day 2
|
74 mmHg
Interval 55.0 to 104.0
|
|
Mean Arterial Pressure (MAP)
Day 3
|
75 mmHg
Interval 62.0 to 105.0
|
|
Mean Arterial Pressure (MAP)
Week 1
|
79 mmHg
Interval 54.0 to 90.0
|
|
Mean Arterial Pressure (MAP)
Prior to explant
|
77 mmHg
Interval 62.0 to 94.0
|
|
Mean Arterial Pressure (MAP)
Post pump day 1
|
73 mmHg
Interval 60.0 to 82.0
|
|
Mean Arterial Pressure (MAP)
Post pump day 2
|
72 mmHg
Interval 62.0 to 87.0
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal.Population: Patients with continuous RVAD support
Cardiac output (L/min) divided by the body surface area (m2)
Outcome measures
| Measure |
Treatment Group
n=9 Participants
Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS
|
|---|---|
|
Cardiac Index (CI)
Baseline
|
2.4 L/min/m2
Interval 1.6 to 3.8
|
|
Cardiac Index (CI)
Day 1
|
2.2 L/min/m2
Interval 1.7 to 5.6
|
|
Cardiac Index (CI)
Day 2
|
2.9 L/min/m2
Interval 1.6 to 5.6
|
|
Cardiac Index (CI)
Day 3
|
3.0 L/min/m2
Interval 1.8 to 4.5
|
|
Cardiac Index (CI)
Week 1
|
7.7 L/min/m2
Interval 7.7 to 7.7
|
|
Cardiac Index (CI)
Prior to explant
|
2.7 L/min/m2
Interval 1.8 to 4.2
|
|
Cardiac Index (CI)
Post pump day 1
|
2.2 L/min/m2
Interval 1.8 to 3.0
|
|
Cardiac Index (CI)
Post pump day 2
|
2.3 L/min/m2
Interval 1.9 to 3.4
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removalPopulation: Patients with continuous RVAD support
BUN is a measure of renal function
Outcome measures
| Measure |
Treatment Group
n=25 Participants
Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS
|
|---|---|
|
Blood Urea Nitrogen (BUN)
Baseline
|
27 mg/dl
Interval 7.0 to 73.0
|
|
Blood Urea Nitrogen (BUN)
Day 1
|
27 mg/dl
Interval 9.0 to 71.0
|
|
Blood Urea Nitrogen (BUN)
Day 2
|
26 mg/dl
Interval 9.0 to 95.0
|
|
Blood Urea Nitrogen (BUN)
Day 3
|
33 mg/dl
Interval 8.0 to 109.0
|
|
Blood Urea Nitrogen (BUN)
Week 1
|
28 mg/dl
Interval 9.0 to 101.0
|
|
Blood Urea Nitrogen (BUN)
Prior to explant
|
22 mg/dl
Interval 10.0 to 67.0
|
|
Blood Urea Nitrogen (BUN)
Post pump day 1
|
28 mg/dl
Interval 12.0 to 72.0
|
|
Blood Urea Nitrogen (BUN)
Post pump day 2
|
31 mg/dl
Interval 14.0 to 79.0
|
|
Blood Urea Nitrogen (BUN)
30 days
|
24 mg/dl
Interval 7.0 to 123.0
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removalPopulation: Patients with continuous RVAD support
Creatinine is a measure of renal function
Outcome measures
| Measure |
Treatment Group
n=25 Participants
Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS
|
|---|---|
|
Creatinine
Baseline
|
1.4 mg/dl
Interval 0.5 to 4.6
|
|
Creatinine
Day 1
|
1.3 mg/dl
Interval 0.6 to 3.7
|
|
Creatinine
Day 2
|
1.1 mg/dl
Interval 0.6 to 4.8
|
|
Creatinine
Day 3
|
1.2 mg/dl
Interval 0.5 to 5.2
|
|
Creatinine
Week 1
|
1.0 mg/dl
Interval 0.6 to 4.5
|
|
Creatinine
Prior to explant
|
1.0 mg/dl
Interval 0.6 to 2.8
|
|
Creatinine
Post pump day 1
|
1.2 mg/dl
Interval 0.6 to 3.7
|
|
Creatinine
Post pump day 2
|
1.3 mg/dl
Interval 0.4 to 4.2
|
|
Creatinine
30 days
|
1.3 mg/dl
Interval 0.6 to 5.5
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removalPopulation: Patients with continuous RVAD support
Total bilirubin is a measure of hepatic function
Outcome measures
| Measure |
Treatment Group
n=24 Participants
Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS
|
|---|---|
|
Total Bilirubin
Baseline
|
1.1 mg/dl
Interval 0.5 to 6.6
|
|
Total Bilirubin
Day 1
|
3.0 mg/dl
Interval 0.6 to 3.7
|
|
Total Bilirubin
Day 2
|
3.0 mg/dl
Interval 0.3 to 7.1
|
|
Total Bilirubin
Day 3
|
2.8 mg/dl
Interval 0.9 to 12.3
|
|
Total Bilirubin
Week 1
|
1.8 mg/dl
Interval 0.7 to 6.4
|
|
Total Bilirubin
Prior to explant
|
1.3 mg/dl
Interval 0.2 to 10.4
|
|
Total Bilirubin
Post pump day 1
|
2.0 mg/dl
Interval 0.7 to 9.9
|
|
Total Bilirubin
Post pump day 2
|
1.3 mg/dl
Interval 0.4 to 7.0
|
|
Total Bilirubin
30 days
|
0.8 mg/dl
Interval 0.2 to 7.2
|
Adverse Events
Treatment Group
Serious events: 24 serious events
Other events: 0 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Treatment Group
n=25 participants at risk
Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS
|
|---|---|
|
Infections and infestations
Infection
|
52.0%
13/25 • Number of events 23 • Baseline through 6 month follow-up
|
|
Blood and lymphatic system disorders
Bleeding
|
64.0%
16/25 • Number of events 40 • Baseline through 6 month follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
64.0%
16/25 • Number of events 19 • Baseline through 6 month follow-up
|
|
Cardiac disorders
Arrhythmias
|
52.0%
13/25 • Number of events 14 • Baseline through 6 month follow-up
|
|
Cardiac disorders
Hypertension
|
20.0%
5/25 • Number of events 9 • Baseline through 6 month follow-up
|
|
Hepatobiliary disorders
Hepatic Dysfunction
|
0.00%
0/25 • Baseline through 6 month follow-up
|
|
Renal and urinary disorders
Renal Failure
|
44.0%
11/25 • Number of events 11 • Baseline through 6 month follow-up
|
|
Nervous system disorders
Neurologic Dysfunction (Stroke)
|
16.0%
4/25 • Number of events 4 • Baseline through 6 month follow-up
|
|
Vascular disorders
Thrombotic Vascular
|
4.0%
1/25 • Number of events 1 • Baseline through 6 month follow-up
|
|
Cardiac disorders
Pericardial Fluid Collection
|
16.0%
4/25 • Number of events 5 • Baseline through 6 month follow-up
|
|
Cardiac disorders
Right Heart Failure
|
24.0%
6/25 • Number of events 7 • Baseline through 6 month follow-up
|
|
Blood and lymphatic system disorders
Hemolysis
|
8.0%
2/25 • Number of events 2 • Baseline through 6 month follow-up
|
|
Product Issues
Device Failure
|
0.00%
0/25 • Baseline through 6 month follow-up
|
|
Cardiac disorders
Myocardial Infarction
|
4.0%
1/25 • Number of events 1 • Baseline through 6 month follow-up
|
|
Psychiatric disorders
Psychiatric Episode
|
4.0%
1/25 • Number of events 1 • Baseline through 6 month follow-up
|
|
Vascular disorders
Arterial non-CNS
|
4.0%
1/25 • Number of events 1 • Baseline through 6 month follow-up
|
|
General disorders
Other
|
28.0%
7/25 • Number of events 17 • Baseline through 6 month follow-up
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER