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Multidisciplinary Clinic Care for Heart Failure (MultiVAD Trial)
N/A
Waitlist Available
Led By Erin Coglianese, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Group A: Ages 18+
Group B: Ages 18+
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post-lvad implantation
Awards & highlights
MultiVAD Trial Summary
This trial will characterize the impact of routine MDT care on health-related quality of life, caregiver burnout and functional capacity of outpatient VAD patients.
Who is the study for?
This trial is for adults with a ventricular assist device (VAD) implanted. Group A includes new VAD patients who haven't had standard follow-up visits, and Group B includes those who have. Participants must be able to complete physical tests and questionnaires. Caregivers of these patients are also included.Check my eligibility
What is being tested?
The study compares the effects of multidisciplinary team care versus standard post-implant care on quality of life, caregiver burnout, and functional capacity in VAD patients. It involves exercise tests, walk tests, and questionnaires for both patients and caregivers.See study design
What are the potential side effects?
Since this trial focuses on different types of care rather than medication or surgery, traditional side effects aren't expected. However, participants may experience fatigue or emotional distress from the assessments.
MultiVAD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am 18 years old or older.
MultiVAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from pre-implant peak vo2 at 12 months post lvad implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from pre-implant peak vo2 at 12 months post lvad implantation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood pressure in mmHg during Cardiopulmonary Exercise Test
EuroQoL (EQ-5D and EuroVAS) to measure quality of life
Heart rate in beats per minute during Cardiopulmonary Exercise Test
+5 moreSecondary outcome measures
Number of VAD related complications
Number of readmissions
Time to readmission in days
MultiVAD Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Prospective interventional cohort of previously-implanted patientsExperimental Treatment1 Intervention
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.
Group II: Prospective interventional cohort of newly-implanted patientsExperimental Treatment1 Intervention
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.
Group III: Primary caregiver cohortExperimental Treatment1 Intervention
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.
Group IV: Retrospective control cohortActive Control1 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.).
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,858 Total Patients Enrolled
48 Trials studying Heart Failure
209,515 Patients Enrolled for Heart Failure
Erin Coglianese, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Group A: People who have not been to regular check-up appointments for VAD care before.People with a ventricular assist device (VAD) implanted.I am 18 years old or older.You have been to regular follow-up visits for VAD care in the past.I cannot perform the 6-minute walk test or CPET.You have a ventricular assist device (VAD) implanted.I am 18 years old or older.I cannot complete a 6-minute walk or a cardiopulmonary exercise test.
Research Study Groups:
This trial has the following groups:- Group 1: Primary caregiver cohort
- Group 2: Retrospective control cohort
- Group 3: Prospective interventional cohort of newly-implanted patients
- Group 4: Prospective interventional cohort of previously-implanted patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for people to enroll in this test currently?
"Clinicaltrials.gov records show that this investigation, which was initially posted on May 1st 2022, is no longer actively accepting applicants. With 701 other trials recruiting right now though, there are still plenty of opportunities to join a clinical trial."
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