Percutaneous RVAD to Preemptively Treat Right Heart Failure Post-LVAD

NCT04458103 | Terminated Results DMC FDA Device

• 1 other identifier: 2020P000422
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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 or intraoperative 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 preemptively receive an RVAD (either the ProtekDuo or Impella RP) surrounding 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 perioperatively 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 peri-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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Vasoactive Inotropic Score

  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.

  first 24 hours post-LVAD implantation

Secondary Outcomes (5)

• Intensive Care Unit Length of Stay

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

• Total Post-operative Length of Stay After LVAD Implantation

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

• Survival at Discharge After LVAD Placement

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

• Survival at 1 Year After LVAD Placement or Heart Transplant

  up to 1 year post-LVAD implantation

• End Organ Dysfunction

  up to 1 year post-LVAD implantation

Study Arms (2)

prospective interventional cohort

EXPERIMENTAL

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.

Device: Percutaneous RVAD

retrospective control cohort

NO INTERVENTION

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.

Interventions

Percutaneous RVAD DEVICE

ProtekDuo or Impella RP

prospective interventional cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Complicated venous access precluding or complicating device placement (i.e. femoral and jugular thrombosis)
• No evidence of right ventricular dysfunction by echocardiogram

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: David D'Alessandro
• Organization: Massachusetts General Hospital

DADALESSANDRO@mgh.harvard.edu

617-726-8841

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: July 7, 2020
• Study Start: May 12, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: July 9, 2024
• Results First Posted: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)