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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post-lvad implantation
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 β€œYes” for the criteria below
Select...
I am between 18 and 75 years old.

Timeline

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

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 more

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.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,785 Total Patients Enrolled
48 Trials studying Heart Failure
209,575 Patients Enrolled for Heart Failure

Media Library

Percutaneous RVAD (Mechanical Circulatory Support Device) Clinical Trial Eligibility Overview. Trial Name: NCT04458103 β€” N/A
Heart Failure Research Study Groups: prospective interventional cohort, retrospective control cohort
Heart Failure Clinical Trial 2023: Percutaneous RVAD Highlights & Side Effects. Trial Name: NCT04458103 β€” N/A
Percutaneous RVAD (Mechanical Circulatory Support Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04458103 β€” N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any opportunity for me to join this clinical investigation?

"To be eligible, volunteers must suffer from heart failure and meet the age criteria of 18-75 years old. The study is seeking to recruit a total of 50 patients."

Answered by AI

What is the upper limit to the number of volunteers involved in this clinical experiment?

"Affirmative. According to data uploaded onto clinicaltrials.gov, this research project is actively searching for volunteers - initially posted on May 12th 2020 and last updated January 7th 2022 - with the aim of recruiting 50 test subjects from one facility."

Answered by AI

Is the age restriction for this trial limited to those over thirty years old?

"This medical study is searching for participants who are between 18 years and 75 years of age."

Answered by AI

Are there still openings in this clinical trial for volunteers?

"The details provided on clinicaltrials.gov indicate that this medical study is still in search of suitable participants – the initial post was made on May 12th 2020, with the latest update being issued January 7th 2022."

Answered by AI
~10 spots leftby Mar 2025