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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

No Placebo-Only Group

Summary

This trial will compare the clinical outcomes of patients who receive perioperative RVAD placement to those who don't in order to see if RVAD placement could be beneficial in preventing RVF.

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 below

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have issues with my veins that make it hard to place medical devices.

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I have a blood clot in the right side of my heart or in a large vein.

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My body cannot accommodate a right ventricular assist device.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post-lvad implantation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Vasoactive Inotropic Score

Secondary study objectives

End Organ Dysfunction

Intensive Care Unit Length of Stay

Survival at 1 Year After LVAD Placement or Heart Transplant

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 5Eligibility criteria met