Right Ventricular Failure
Conditions
Keywords
Heart Failure, Right Ventricular Failure, Levitronix, Thoratec Corporation
Brief summary
The study objective is to gather post-market clinical data on the use of the CentriMag RVAS when used for temporary mechanical circulatory support of the right ventricle in patients with acute right ventricular failure from any cause
Detailed description
Objectives of this study are to evaluate: 1. Duration of right ventricular support 2. Incidence of adverse effects 3. Evaluation of end-organ function 4. Evaluation of hemodynamics 5. Survival at 30 days post RVAD removal The primary endpoints include: 1. In patients who recover and do not go on to transplantation or a long-term device: a. Survival to 30 days post-support or to hospital discharge (whichever is longer) 2. In patients who do not recover and are bridged to transplant or a long-term system: 1. Survival to induction of anesthesia for implantation of a long-term mechanical support device or heart transplant Secondary endpoints include: 1. On Pump Hemodynamics 1. A clearly observable trend toward reduction of mean right atrial pressure / central venous pressure is demonstrated while the patient is on support compared to baseline. 2. A clearly observable trend toward an increase in mean arterial pressure is demonstrated while the patient is on support compared to baseline 3. A clearly observable trend toward an increase in mean cardiac index is demonstrated while the patient is on support compared to baseline 2. Post Pump Hemodynamics (must meet at least two of the following criteria) 1. Based on plotting of the data, success will be achieved if a clearly observable trend toward reduction of mean right atrial pressure/central venous pressure is demonstrated after device removal compared to baseline 2. Based on plotting of the data, success will be achieved if a clearly observable trend toward increase in mean arterial pressure is demonstrated after device removal compared to baseline 3. Based on plotting of the data, success will be achieved if a clearly observable trend toward increase in mean cardiac index is demonstrated after device removal compared to baseline 3. A clearly observable trend toward a reduction in creatinine and/or BUN while on support and after device removal compared to baseline 4. A clearly observable trend toward a reduction in total bilirubin while on support and after device removal compared to baseline 5. An acceptable incidence of adverse effects observed Patient Population This study includes data from 25 consecutive patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
Interventions
DEVICECentriMag RVAS placement
Patients will be treated with a CentriMag RVAS
Sponsors
Thoratec Corporation
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Right ventricular failure from any cause
Exclusion criteria
* Primary coagulopathy or platelet disorders * Allergy or sensitivity to heparin and all alternative anticoagulants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 30 days post device removal | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Arterial Pressure (MAP) | Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal. | 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. |
| Cardiac Index (CI) | Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal. | Cardiac output (L/min) divided by the body surface area (m2) |
| Central Venous Pressure (CVP) | Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal | 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. |
| Creatinine | 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 removal | Creatinine is a measure of renal function |
| Total Bilirubin | 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 removal | Total bilirubin is a measure of hepatic function |
| Blood Urea Nitrogen (BUN) | 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 removal | BUN is a measure of renal function |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Continuous | 53 Years STANDARD_DEVIATION 13.9 |
| Blood Urea Nitrogen (BUN) | 27 mg/dl |
| Cardiac Index (CI) | 2.4 L/min/m^2 |
| Central Venous Pressure (CVP) | 11 mmHg |
| Creatinine (mg/dl) | 1.4 mg/dl |
| Mean Arterial Pressure (MAP) | 72 mmHg |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 20 Participants |
| Total Bilirubin (mg/dl) | 1.1 mg/dl |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 24 / 25 |
Outcome results
Primary
Survival
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.
Time frame: 30 days post device removal
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group | Survival | 80 percentage of survival at 30 days |
Secondary
Blood Urea Nitrogen (BUN)
BUN is a measure of renal function
Time frame: 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 removal
Population: Patients with continuous RVAD support
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Group | Blood Urea Nitrogen (BUN) | Baseline | 27 mg/dl |
| Treatment Group | Blood Urea Nitrogen (BUN) | Day 1 | 27 mg/dl |
| Treatment Group | Blood Urea Nitrogen (BUN) | Day 2 | 26 mg/dl |
| Treatment Group | Blood Urea Nitrogen (BUN) | Day 3 | 33 mg/dl |
| Treatment Group | Blood Urea Nitrogen (BUN) | Week 1 | 28 mg/dl |
| Treatment Group | Blood Urea Nitrogen (BUN) | Prior to explant | 22 mg/dl |
| Treatment Group | Blood Urea Nitrogen (BUN) | Post pump day 1 | 28 mg/dl |
| Treatment Group | Blood Urea Nitrogen (BUN) | Post pump day 2 | 31 mg/dl |
| Treatment Group | Blood Urea Nitrogen (BUN) | 30 days | 24 mg/dl |
Secondary
Cardiac Index (CI)
Cardiac output (L/min) divided by the body surface area (m2)
Time frame: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Group | Cardiac Index (CI) | Baseline | 2.4 L/min/m2 |
| Treatment Group | Cardiac Index (CI) | Day 1 | 2.2 L/min/m2 |
| Treatment Group | Cardiac Index (CI) | Day 2 | 2.9 L/min/m2 |
| Treatment Group | Cardiac Index (CI) | Day 3 | 3.0 L/min/m2 |
| Treatment Group | Cardiac Index (CI) | Week 1 | 7.7 L/min/m2 |
| Treatment Group | Cardiac Index (CI) | Prior to explant | 2.7 L/min/m2 |
| Treatment Group | Cardiac Index (CI) | Post pump day 1 | 2.2 L/min/m2 |
| Treatment Group | Cardiac Index (CI) | Post pump day 2 | 2.3 L/min/m2 |
Secondary
Central Venous Pressure (CVP)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Group | Central Venous Pressure (CVP) | Baseline | 11 mmHg |
| Treatment Group | Central Venous Pressure (CVP) | Day 1 | 11 mmHg |
| Treatment Group | Central Venous Pressure (CVP) | Day 2 | 10 mmHg |
| Treatment Group | Central Venous Pressure (CVP) | Day 3 | 12 mmHg |
| Treatment Group | Central Venous Pressure (CVP) | Week 1 | 11 mmHg |
| Treatment Group | Central Venous Pressure (CVP) | Prior to explant | 10 mmHg |
| Treatment Group | Central Venous Pressure (CVP) | Post pump day 1 | 12 mmHg |
| Treatment Group | Central Venous Pressure (CVP) | Post pump day 2 | 11 mmHg |
Secondary
Creatinine
Creatinine is a measure of renal function
Time frame: 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 removal
Population: Patients with continuous RVAD support
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Group | Creatinine | Baseline | 1.4 mg/dl |
| Treatment Group | Creatinine | Day 1 | 1.3 mg/dl |
| Treatment Group | Creatinine | Day 2 | 1.1 mg/dl |
| Treatment Group | Creatinine | Day 3 | 1.2 mg/dl |
| Treatment Group | Creatinine | Week 1 | 1.0 mg/dl |
| Treatment Group | Creatinine | Prior to explant | 1.0 mg/dl |
| Treatment Group | Creatinine | Post pump day 1 | 1.2 mg/dl |
| Treatment Group | Creatinine | Post pump day 2 | 1.3 mg/dl |
| Treatment Group | Creatinine | 30 days | 1.3 mg/dl |
Secondary
Mean Arterial Pressure (MAP)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Group | Mean Arterial Pressure (MAP) | Prior to explant | 77 mmHg |
| Treatment Group | Mean Arterial Pressure (MAP) | Post pump day 1 | 73 mmHg |
| Treatment Group | Mean Arterial Pressure (MAP) | Post pump day 2 | 72 mmHg |
| Treatment Group | Mean Arterial Pressure (MAP) | Baseline | 72 mmHg |
| Treatment Group | Mean Arterial Pressure (MAP) | Day 1 | 74 mmHg |
| Treatment Group | Mean Arterial Pressure (MAP) | Day 2 | 74 mmHg |
| Treatment Group | Mean Arterial Pressure (MAP) | Day 3 | 75 mmHg |
| Treatment Group | Mean Arterial Pressure (MAP) | Week 1 | 79 mmHg |
Secondary
Total Bilirubin
Total bilirubin is a measure of hepatic function
Time frame: 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 removal
Population: Patients with continuous RVAD support
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Group | Total Bilirubin | Baseline | 1.1 mg/dl |
| Treatment Group | Total Bilirubin | Day 1 | 3.0 mg/dl |
| Treatment Group | Total Bilirubin | Day 2 | 3.0 mg/dl |
| Treatment Group | Total Bilirubin | Day 3 | 2.8 mg/dl |
| Treatment Group | Total Bilirubin | Week 1 | 1.8 mg/dl |
| Treatment Group | Total Bilirubin | Prior to explant | 1.3 mg/dl |
| Treatment Group | Total Bilirubin | Post pump day 1 | 2.0 mg/dl |
| Treatment Group | Total Bilirubin | Post pump day 2 | 1.3 mg/dl |
| Treatment Group | Total Bilirubin | 30 days | 0.8 mg/dl |