Multidisciplinary Ventricular Assist Device Clinic

NCT05388019 | Enrolling By Invitation

• 1 other identifier: 2021P00351
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Current standard of care for ventricular-assist device (VAD) patients is composed of a multidisciplinary team (MDT), which is required in pre-implant and implant hospitalization care but is lacking in post-implant care. Post-implant care is currently centered around the avoidance of complications of VAD support, including cerebrovascular insult (CVA/TIA), gastrointestinal bleeding and infection. Despite major improvements in survival for VAD patients, quality of life and physical functioning measures have not seen significant improvements. This study will include two prospective interventional cohorts and a retrospective control cohort. The first prospective interventional cohort will consist of patients who recently underwent LVAD implantation at Massachusetts General Hospital, and their caregivers. These patients will receive only multidisciplinary team care from the time of their implant. The second prospective interventional cohort will consist of patients who have previously undergone LVAD implantation at Massachusetts General Hospital who are being followed-up with standard-of-care VAD clinic visits, and their caregivers. These patients will receive a hybrid of multidisciplinary team care and standard-of-care visits. The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past and no longer have an LVAD implanted (due to transplant, death, explant, etc.), and will be matched with the prospective interventional patients. The purpose of this study is to characterize the impact of routine MDT care on health-related quality of life, caregiver burnout and functional capacity of outpatient VAD patients, and to determine if implementation of MDT care is associated with a reduction in complications and readmissions in VAD patients at one- and two-years post implant. The investigators hypothesize that the MDT clinic model in addition to standard of care VAD management will positively impact the quality of life and functional status of VAD patients. Subjects who consent to this study will be seen by the MDT providers and complete Cardiopulmonary Exercise Tests (CPET), six-minute-walk-tests, and quality of life questionnaires. The primary caregivers of these subjects will complete a Caregiver Self-Assessment at two timepoints. We anticipate to enroll 20 newly-implanted VAD patients in the pure-MDT arm, 35 pre-existing VAD patients in hybrid-MDT/SOC arm, and 55 primary caregivers.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (8)

• Peak VO2 in mL/kg of body weight/min during Cardiopulmonary Exercise Test

  Retrospective review in a patient chart.

  Change from pre-implant peak VO2 at 12 months post LVAD implantation

• Respiratory Exchange Ratio (RER) in % during Cardiopulmonary Exercise Test

  Retrospective review in a patient chart.

  Change from pre-implant RER at 12 months post LVAD implantation

• Minute ventilation per carbon dioxide production (VE/VCO2) during Cardiopulmonary Exercise Test

  Retrospective review in a patient chart.

  Change from pre-implant VE/VCO2 at 12 months post LVAD implantation

• Systolic and diastolic blood pressure in mmHg during Cardiopulmonary Exercise Test

  Retrospective review in a patient chart.

  Change from pre-implant blood pressure at 12 months post LVAD implantation

• Heart rate in beats per minute during Cardiopulmonary Exercise Test

  Retrospective review in a patient chart.

  Change from pre-implant heart rate at 12 months post LVAD implantation

• EuroQoL (EQ-5D and EuroVAS) to measure quality of life

  Survey administered by research coordinator.

  Change from pre-implant up to 12 months post LVAD implantation

• Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure quality of life

  Survey administered by research coordinator

  Change from pre-implant up to 12 months post LVAD implantation

• Montreal Cognitive Assessment (MoCA) to measure cognitive function

  Assessment administered by Occupational Therapist

  Change from pre-implant up to 12 months post LVAD implantation

Secondary Outcomes (3)

• Number of readmissions

  up to 24 months post-LVAD implantation

• Time to readmission in days

  up to 24 months post-LVAD implantation

• Number of VAD related complications

  up to 24 months post-LVAD implantation

Study Arms (4)

Prospective interventional cohort of newly-implanted patients

EXPERIMENTAL

This cohort will consist of patients who recently underwent LVAD implantation at Massachusetts General Hospital, and their caregivers. These patients will receive only multidisciplinary team care from the time of their implant.

Other: Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires)

Prospective interventional cohort of previously-implanted patients

EXPERIMENTAL

This cohort will consist of patients who have previously undergone LVAD implantation at Massachusetts General Hospital who are being followed-up with standard-of-care VAD clinic visits, and their caregivers. These patients will receive a hybrid of multidisciplinary team care and standard-of-care visits.

Other: Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires)

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 and no longer have an LVAD implanted (due to transplant, death, explant, etc.).

Primary caregiver cohort

EXPERIMENTAL

This cohort will consist of primary caregivers of VAD patients from the two interventional cohorts. They will be administered a questionnaire at two timepoints. Each VAD patient will be associated with only one primary caregiver for the duration of the study.

Behavioral: Caregiver Self-Assessment

Interventions

Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires) OTHER

Subject will receive care from a multidisciplinary team (physical therapy, occupational therapy, palliative care, social work) in addition to their standard of care VAD clinic visits. Subject will also perform a CPET, six-minute-walk-test, MoCA, and be administered quality of life questionnaires.

Prospective interventional cohort of newly-implanted patients; Prospective interventional cohort of previously-implanted patients

Caregiver Self-Assessment BEHAVIORAL

Primary caregivers of both interventional VAD patient cohorts will be administered a Caregiver Self-Assessment to assess burnout.

Primary caregiver cohort

Eligibility Criteria

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

You may qualify if:

• Ages 18+
• Individuals with ventricular assist device (VAD) implanted
• Individuals who have not previously attended standard-of-care VAD follow-up clinic visits

You may not qualify if:

• Inability to answer quality of life questionnaires
• Inability to perform the 6-minute walk test and Cardiopulmonary Exercise Test (CPET)
• Individuals who have previously attended standard-of-care VAD follow-up clinic visits
• Ages 18+
• Individuals with ventricular assist device (VAD) implanted
• Individuals who have previously attended standard-of-care VAD follow-up clinic visits
• Inability to answer quality of life questionnaires
• Inability to perform the 6-minute walk test and CPET

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Tractenberg RE, Yumoto F, Aisen PS. Detecting When "Quality of Life" Has Been "Enhanced": Estimating Change in Quality of Life Ratings. Open J Philos. 2013 Nov 1;3(4A):24-31. doi: 10.4236/ojpp.2013.34A005.

  PMID: 26213645 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Erin Coglianese, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Mechanical Cardiac Support Program

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 24, 2022
• Study Start: April 21, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

US (1)