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Preoperative Percutaneous RVAD to Preemptively Treat Right Heart Failure Post-LVAD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04458103
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
David A. D'Alessandro, M.D., Massachusetts General Hospital

Brief Summary:

Prior studies have shown that left ventricular assist device (LVAD) implantation commonly results in right ventricular failure (RVF). Right ventricular dysfunction and failure after LVAD implantation is known to increase morbidity and mortality and contribute to longer post-implant hospital length of stay. Since RVF is difficult to predict and can have harmful effects such as increased ICU stay, adverse outcomes, and mortality, it could be beneficial to preemptively treat patients through preoperative percutaneous right ventricular assist device (RVAD) placement to prevent RVF.

This trial will include both a prospective interventional cohort and a retrospective control 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 LVAD implantation. The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past. This group will be matched with the enrolled prospective interventional patients. The purpose of this study is to compare clinical outcomes of standard of care treatment versus percutaneous RVAD placement preoperatively to LVAD implantation. The investigators hypothesize that the use of the RVAD will mitigate need for inotropic support, reducing the vasoactive-inotrope score (VIS) by 50%, and will improve end organ function in patients compared to standard of care.

Subjects who consent to the study will undergo pre-operative placement of an RVAD, which will be left in up to 72 hours postoperatively. The type of RVAD (Impella RP or ProtekDuo) inserted will be determined by patient needs and venous access and will be up to the discretion of the treating physician. 25 subjects will be enrolled in the prospective interventional cohort and compared to 25 subjects in the matched retrospective control cohort.


Condition or disease Intervention/treatment Phase
Heart Failure Device: Percutaneous RVAD Not Applicable

Detailed Description:

Prior studies have shown that left ventricular assist device (LVAD) implantation commonly results in right ventricular failure (RVF). Right ventricular dysfunction and failure after LVAD implantation is known to increase morbidity and mortality and contribute to longer post-implant hospital length of stay. More severe right ventricular failure is highly correlated with poor prognosis and death post-LVAD implantation. In current practice, patients who receive LVADs require right heart support, provided in the form of inotropes. Vasoactive inotrope score (VIS) is a measure that quantifies the amount of right heart support required post-operatively, including dopamine, dobutamine, milrinone, epinephrine, norepinephrine, and vasopressin. It has been used in other studies as a surrogate marker for hemodynamic cardiovascular derangement.

In some cases, right ventricular failure post-LVAD also requires mechanical circulatory support during the perioperative period. Since RVF is difficult to predict and can have harmful effects such as increased ICU stay, adverse outcomes, and mortality, it could be beneficial to preemptively treat patients through preoperative percutaneous right ventricular assist device (RVAD) placement to prevent RVF. The purpose of this study is to test the hypothesis that preemptive use of percutaneous RVADs will mitigate the need for inotropic support in LVAD patients, reducing associated adverse outcomes.

This trial will include both a prospective interventional cohort and a retrospective control 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 LVAD implantation. The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past. This group will be matched with the enrolled prospective interventional patients. The purpose of this study is to compare clinical outcomes of standard of care treatment versus percutaneous RVAD placement preoperatively to LVAD implantation. The investigators hypothesize that the use of the RVAD will mitigate need for inotropic support, reducing the vasoactive-inotrope score (VIS) by 50%, and will improve end organ function in patients compared to standard of care.

There are two types of percutaneous RVADs that will be used in the study: the Impella RP and the ProtekDuo. These devices allow for early intervention in RVF without the need for invasive surgical procedures requiring placement of durable RVADs via thoracotomy or sternotomy. The Impella RP, manufactured by Abiomed, is a heart pump that delivers blood from the inferior vena cava (IVC) to the pulmonary artery (PA). Its insertion is done percutaneously via catheterization through the femoral vein. ProtekDuo, manufactured by TandemLife, is another device placed percutaneously for right heart support via the right internal jugular (RIJ) vein.

Subjects who consent to the study will undergo pre-operative placement of an RVAD, which will be left in up to 72 hours postoperatively. The type of RVAD (Impella RP or ProtekDuo) inserted will be determined by patient needs and venous access and will be up to the discretion of the treating physician. 25 subjects will be enrolled in the prospective interventional cohort and compared to 25 subjects in the matched retrospective control cohort.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preoperative Percutaneous RVAD to Preemptively Treat Right Heart Failure Post-LVAD
Actual Study Start Date : May 12, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: 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 LVAD implantation.
Device: Percutaneous RVAD
ProtekDuo or Impella RP

No Intervention: 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.



Primary Outcome Measures :
  1. Vasoactive Inotropic Score [ Time Frame: 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. It is hypothesized that a higher score will correspond with worse outcomes.


Secondary Outcome Measures :
  1. Total Vasoactive Inotropic Score [ Time Frame: up to date of hospital discharge (estimated average = 3 weeks) ]
    Retrospective review in a patient chart. Calculated based on dosages of inotropes and vasopressors from time of LVAD implantation to hospital discharge.

  2. Intensive Care Unit length of stay [ Time Frame: up to date of discharge from intensive care unit (estimated average = 1 week) ]
    Retrospective review in a patient chart

  3. Total post-operative length of stay after LVAD implantation [ Time Frame: up to date of hospital discharge (estimated average = 3 weeks) ]
    Retrospective review in a patient chart

  4. Survival at discharge after LVAD placement [ Time Frame: up to date of hospital discharge (estimated average = 3 weeks) ]
    Retrospective review in a patient chart

  5. Survival at 1 year after LVAD placement or heart transplant [ Time Frame: up to 1 year post-LVAD implantation ]
    Retrospective review in a patient chart

  6. End organ dysfunction [ Time Frame: 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; 2) Liver dysfunction

  7. LVAD Device Speed [ Time Frame: measured up to 1 year post-LVAD implantation ]
    Retrospective review in a patient chart



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 18-75
  • Accepted for LVAD implantation by MGH multidisciplinary team

Exclusion Criteria:

  • Severe tricuspid valve regurgitation in a patient where a valve intervention is expected
  • Disorders of the pulmonary artery wall that would preclude placement or correct positioning of RVAD
  • Presence of mechanical valves
  • Mural thrombosis of the right atrium or vena cava
  • Anatomic conditions precluding insertion of the RVAD
  • Known or expected PFO closure
  • Complicated venous access precluding or complicating device placement (i.e. femoral and jugular thrombosis)
  • No evidence of right ventricular dysfunction by echocardiogram

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458103


Contacts
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Contact: David D'Alessandro, MD 617-726-8841 DADALESSANDRO@MGH.HARVARD.EDU
Contact: Monica Prario 617-726-8332 mprario@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by David A. D'Alessandro, M.D., Massachusetts General Hospital:
Study Protocol  [PDF] April 21, 2020

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Responsible Party: David A. D'Alessandro, M.D., Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04458103    
Other Study ID Numbers: 2020P000422
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases