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NCT05388019

Multidisciplinary Ventricular Assist Device Clinic

Enrolling by Invitation
NAAges 18+InterventionalTreatment
Massachusetts General Hospital
~110 participants
Updated 2025-12-30 on ClinicalTrials.gov
What's tested:Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires)Caregiver Self-Assessment

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peak VO2 in mL/kg of body weight/min during Cardiopulmonary Exercise Test
Measured over Change from pre-implant peak VO2 at 12 months post LVAD implantation
+7 more outcomes measured

Conditions

Heart Failure

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Heart Failure

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Erin Coglianese, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Ages 18+
Individuals with ventricular assist device (VAD) implanted
Individuals who have not 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

Exclusion

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
Inability to answer quality of life questionnaires
Inability to perform the 6-minute walk test and CPET

What this trial measures

  • Peak VO2 in mL/kg of body weight/min during Cardiopulmonary Exercise TestChange from pre-implant peak VO2 at 12 months post LVAD implantation

    Retrospective review in a patient chart.

  • Respiratory Exchange Ratio (RER) in % during Cardiopulmonary Exercise TestChange from pre-implant RER at 12 months post LVAD implantation

    Retrospective review in a patient chart.

  • Minute ventilation per carbon dioxide production (VE/VCO2) during Cardiopulmonary Exercise TestChange from pre-implant VE/VCO2 at 12 months post LVAD implantation

    Retrospective review in a patient chart.

  • Systolic and diastolic blood pressure in mmHg during Cardiopulmonary Exercise TestChange from pre-implant blood pressure at 12 months post LVAD implantation

    Retrospective review in a patient chart.

  • Heart rate in beats per minute during Cardiopulmonary Exercise TestChange from pre-implant heart rate at 12 months post LVAD implantation

    Retrospective review in a patient chart.

  • EuroQoL (EQ-5D and EuroVAS) to measure quality of lifeChange from pre-implant up to 12 months post LVAD implantation

    Survey administered by research coordinator.

  • Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure quality of lifeChange from pre-implant up to 12 months post LVAD implantation

    Survey administered by research coordinator

  • Montreal Cognitive Assessment (MoCA) to measure cognitive functionChange from pre-implant up to 12 months post LVAD implantation

    Assessment administered by Occupational Therapist