Trial Outcomes & Findings for Percutaneous RVAD to Preemptively Treat Right Heart Failure Post-LVAD (NCT NCT04458103)

NCT ID: NCT04458103

Last Updated: 2024-07-09

Results Overview

Retrospective review in a patient chart. Score calculated based on dosages of vasopressors and inotropes within first 24-hours post-LVAD implant. The maximum Vasoactive Inotropic Score within the first 24-hours is reported. Vasoactive Inotropic Score= dopamine (μg/kg/min) + dobutamine (μg/kg/min) + 10 x milrinone (μg/kg/min) + 100 x epinephrine (μg/kg/min) + 100 x norepinephrine (μg/kg/min) + 10,000 x vasopressin (U/kg/min). Minimum possible vasoactive inotropic score is 0. It is hypothesized that a higher score will correspond with worse outcomes.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 161 participants
• Primary outcome timeframe: first 24 hours post-LVAD implantation
• Results posted on: 2024-07-09

Participant Flow

Participant milestones

Measure	Prospective Interventional Cohort The prospective interventional cohort will consist of patients undergoing LVAD implantation at Massachusetts General Hospital. These patients will receive an RVAD (either the ProtekDuo or Impella RP) prior to or during LVAD implantation. Percutaneous RVAD: ProtekDuo or Impella RP	Retrospective Control Cohort The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past. This group will be age and sex matched with the enrolled prospective interventional patients.
Overall Study STARTED	17	144
Overall Study COMPLETED	17	144
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Percutaneous RVAD to Preemptively Treat Right Heart Failure Post-LVAD

Baseline characteristics by cohort

Measure	Prospective Interventional Cohort n=17 Participants The prospective interventional cohort will consist of patients undergoing LVAD implantation at Massachusetts General Hospital. These patients will receive an RVAD (either the ProtekDuo or Impella RP) prior to or during LVAD implantation. Percutaneous RVAD: ProtekDuo or Impella RP	Retrospective Control Cohort n=144 Participants The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past. This group will be age and sex matched with the enrolled prospective interventional patients.	Total n=161 Participants Total of all reporting groups
Age, Continuous	59.41 years STANDARD_DEVIATION 13.97 • n=93 Participants	58.13 years STANDARD_DEVIATION 13.31 • n=4 Participants	58.3 years STANDARD_DEVIATION 13.3 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	34 Participants n=4 Participants	38 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	110 Participants n=4 Participants	123 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	15 Participants n=4 Participants	16 Participants n=27 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants	111 Participants n=4 Participants	123 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	14 Participants n=4 Participants	16 Participants n=27 Participants
Region of Enrollment United States	17 participants n=93 Participants	144 participants n=4 Participants	161 participants n=27 Participants

PRIMARY outcome

Timeframe: first 24 hours post-LVAD implantation

Retrospective review in a patient chart. Score calculated based on dosages of vasopressors and inotropes within first 24-hours post-LVAD implant. The maximum Vasoactive Inotropic Score within the first 24-hours is reported.

Vasoactive Inotropic Score= dopamine (μg/kg/min) + dobutamine (μg/kg/min) + 10 x milrinone (μg/kg/min) + 100 x epinephrine (μg/kg/min) + 100 x norepinephrine (μg/kg/min) + 10,000 x vasopressin (U/kg/min).

Minimum possible vasoactive inotropic score is 0. It is hypothesized that a higher score will correspond with worse outcomes.

Outcome measures

Measure	Prospective Interventional Cohort n=17 Participants The prospective interventional cohort will consist of patients undergoing LVAD implantation at Massachusetts General Hospital. These patients will receive an RVAD (either the ProtekDuo or Impella RP) prior to or during LVAD implantation. Percutaneous RVAD: ProtekDuo or Impella RP	Retrospective Control Cohort n=144 Participants The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past. This group will be age and sex matched with the enrolled prospective interventional patients.
Vasoactive Inotropic Score	36.4 Vasoactive Inotropic Score Standard Deviation 103.1	47.46 Vasoactive Inotropic Score Standard Deviation 84.8

SECONDARY outcome

Timeframe: up to date of discharge from intensive care unit (estimated average = 1 week)

Retrospective review in a patient chart

Outcome measures

Measure	Prospective Interventional Cohort n=17 Participants The prospective interventional cohort will consist of patients undergoing LVAD implantation at Massachusetts General Hospital. These patients will receive an RVAD (either the ProtekDuo or Impella RP) prior to or during LVAD implantation. Percutaneous RVAD: ProtekDuo or Impella RP	Retrospective Control Cohort n=144 Participants The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past. This group will be age and sex matched with the enrolled prospective interventional patients.
Intensive Care Unit Length of Stay	14.1 days Standard Deviation 14.9	11.1 days Standard Deviation 13.7

SECONDARY outcome

Timeframe: up to date of hospital discharge (estimated average = 3 weeks)

Retrospective review in a patient chart

Outcome measures

Measure	Prospective Interventional Cohort n=17 Participants The prospective interventional cohort will consist of patients undergoing LVAD implantation at Massachusetts General Hospital. These patients will receive an RVAD (either the ProtekDuo or Impella RP) prior to or during LVAD implantation. Percutaneous RVAD: ProtekDuo or Impella RP	Retrospective Control Cohort n=144 Participants The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past. This group will be age and sex matched with the enrolled prospective interventional patients.
Total Post-operative Length of Stay After LVAD Implantation	30.2 days Standard Deviation 31.1	24.9 days Standard Deviation 17.8

SECONDARY outcome

Timeframe: up to date of hospital discharge (estimated average = 3 weeks)

Retrospective review in a patient chart

Outcome measures

Measure	Prospective Interventional Cohort n=17 Participants The prospective interventional cohort will consist of patients undergoing LVAD implantation at Massachusetts General Hospital. These patients will receive an RVAD (either the ProtekDuo or Impella RP) prior to or during LVAD implantation. Percutaneous RVAD: ProtekDuo or Impella RP	Retrospective Control Cohort n=144 Participants The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past. This group will be age and sex matched with the enrolled prospective interventional patients.
Survival at Discharge After LVAD Placement	13 Participants	139 Participants

SECONDARY outcome

Timeframe: up to 1 year post-LVAD implantation

Retrospective review in a patient chart

Outcome measures

Measure	Prospective Interventional Cohort n=17 Participants The prospective interventional cohort will consist of patients undergoing LVAD implantation at Massachusetts General Hospital. These patients will receive an RVAD (either the ProtekDuo or Impella RP) prior to or during LVAD implantation. Percutaneous RVAD: ProtekDuo or Impella RP	Retrospective Control Cohort n=144 Participants The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past. This group will be age and sex matched with the enrolled prospective interventional patients.
Survival at 1 Year After LVAD Placement or Heart Transplant	13 Participants	139 Participants

SECONDARY outcome

Timeframe: up to 1 year post-LVAD implantation

end organ dysfunction including 1) Development of acute kidney injury (AKI) - defined as increase in serum creatinine (sCr) to 4mg/dl or greater, a 150 percent or greater increase in sCr over the baseline preoperative value, or a new requirement for renal replacement therapy

Outcome measures

Measure	Prospective Interventional Cohort n=17 Participants The prospective interventional cohort will consist of patients undergoing LVAD implantation at Massachusetts General Hospital. These patients will receive an RVAD (either the ProtekDuo or Impella RP) prior to or during LVAD implantation. Percutaneous RVAD: ProtekDuo or Impella RP	Retrospective Control Cohort n=144 Participants The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past. This group will be age and sex matched with the enrolled prospective interventional patients.
End Organ Dysfunction	5 Participants	27 Participants

Adverse Events

Prospective Interventional Cohort

Serious events: 16 serious events

Other events: 8 other events

Deaths: 4 deaths

Retrospective Control Cohort

Serious events: 135 serious events

Other events: 74 other events

Deaths: 13 deaths

Serious adverse events

Measure	Prospective Interventional Cohort n=17 participants at risk The prospective interventional cohort will consist of patients undergoing LVAD implantation at Massachusetts General Hospital. These patients will receive an RVAD (either the ProtekDuo or Impella RP) prior to or during LVAD implantation. Percutaneous RVAD: ProtekDuo or Impella RP	Retrospective Control Cohort n=144 participants at risk The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past. This group will be age and sex matched with the enrolled prospective interventional patients.
Blood and lymphatic system disorders Bleed	35.3% 6/17 • 1year INTERMACS Adverse Event Definitions	38.9% 56/144 • 1year INTERMACS Adverse Event Definitions
Nervous system disorders Neurological Event	17.6% 3/17 • 1year INTERMACS Adverse Event Definitions	9.0% 13/144 • 1year INTERMACS Adverse Event Definitions
Infections and infestations Infection	41.2% 7/17 • 1year INTERMACS Adverse Event Definitions	45.8% 66/144 • 1year INTERMACS Adverse Event Definitions

Other adverse events

Measure	Prospective Interventional Cohort n=17 participants at risk The prospective interventional cohort will consist of patients undergoing LVAD implantation at Massachusetts General Hospital. These patients will receive an RVAD (either the ProtekDuo or Impella RP) prior to or during LVAD implantation. Percutaneous RVAD: ProtekDuo or Impella RP	Retrospective Control Cohort n=144 participants at risk The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past. This group will be age and sex matched with the enrolled prospective interventional patients.
Renal and urinary disorders Renal Dysfunction	29.4% 5/17 • 1year INTERMACS Adverse Event Definitions	18.8% 27/144 • 1year INTERMACS Adverse Event Definitions
Cardiac disorders Arrhythmia	29.4% 5/17 • 1year INTERMACS Adverse Event Definitions	31.9% 46/144 • 1year INTERMACS Adverse Event Definitions
Respiratory, thoracic and mediastinal disorders Respiratory Dysfunction	29.4% 5/17 • 1year INTERMACS Adverse Event Definitions	17.4% 25/144 • 1year INTERMACS Adverse Event Definitions
Hepatobiliary disorders Hepatic Dysfunction	5.9% 1/17 • 1year INTERMACS Adverse Event Definitions	0.00% 0/144 • 1year INTERMACS Adverse Event Definitions

Additional Information

David D'Alessandro

Massachusetts General Hospital

Phone: 617-726-8841

Email: DADALESSANDRO@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place