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Mechanical Circulatory Support Device
Percutaneous RVAD for Preventing Right Heart Failure
N/A
Waitlist Available
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 18-75
Be older than 18 years old
Must not have
Complicated venous access precluding or complicating device placement (i.e. femoral and jugular thrombosis)
Mural thrombosis of the right atrium or vena cava
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post-lvad implantation
Awards & highlights
Summary
Percutaneous RVAD to Preemptively Treat Right Heart Failure Post-LVAD
Who is the study for?
This trial is for adults aged 18-75 approved for a heart pump implant (LVAD) at Massachusetts General Hospital, without right heart dysfunction on ultrasound, no issues with the pulmonary artery wall, mechanical valves or clots in the heart or large veins that would interfere with placing another device called RVAD.
What is being tested?
The study tests if putting in an RVAD device around the time of LVAD implantation can prevent right heart failure. It compares patients getting this new approach to past patients who didn't get it. The goal is to see if using RVAD reduces ICU stays and improves organ function compared to usual care.
What are the potential side effects?
Potential side effects may include complications from inserting the RVAD such as bleeding, infection risk at the insertion site, possible damage to blood vessels or organs near where the device goes in, and general risks associated with having an additional medical device inside one's body.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have issues with my veins that make it hard to place medical devices.
Select...
I have a blood clot in the right side of my heart or in a large vein.
Select...
My body cannot accommodate a right ventricular assist device.
Select...
My pulmonary artery condition doesn't allow for RVAD placement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year post-lvad implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year 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
Vasoactive Inotropic Score
Secondary outcome measures
End organ dysfunction
Intensive Care Unit length of stay
LVAD Device Speed
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: prospective interventional cohortExperimental Treatment1 Intervention
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.
Group II: 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. This group will be age and sex matched with the enrolled prospective interventional patients.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,955 Previous Clinical Trials
13,212,628 Total Patients Enrolled
49 Trials studying Heart Failure
212,605 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have issues with my veins that make it hard to place medical devices.I have a blood clot in the right side of my heart or in a large vein.You have a mechanical heart valve.My body cannot accommodate a right ventricular assist device.My pulmonary artery condition doesn't allow for RVAD placement.I am between 18 and 75 years old.Your heart ultrasound does not show any issues with the right side of your heart.
Research Study Groups:
This trial has the following groups:- Group 1: retrospective control cohort
- Group 2: prospective interventional cohort
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.
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