Your session is about to expire
← Back to Search
Device
Tricuspid Valve Repair + LVAD for Heart Failure
N/A
Recruiting
Led By Kei Togashi, MD, MPH
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant with advanced heart failure symptoms (Class III or IV) and preoperative mild tricuspid regurgitation who are scheduled for an implantable LVAD
Over 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 months
Awards & highlights
Study Summary
This trial is studying whether surgical correction of mild to moderate tricuspid valve regurgitation (TR) in people also undergoing left ventricular assist device (LVAD) implantation will reduce right ventricular dysfunction and have a positive impact on health outcomes.
Who is the study for?
This trial is for adults over 18 with advanced heart failure symptoms who are scheduled for an LVAD implant and have mild tricuspid regurgitation. It's not for pregnant individuals, those with psychiatric or severe cognitive issues, uncontrolled infections, other life-limiting conditions, high surgical risk as judged by the investigator, participation in confounding studies, inmates, liver disease patients, recent stroke victims or significant cerebral vascular disease sufferers.Check my eligibility
What is being tested?
The study examines if surgically fixing the tricuspid valve at the same time as implanting a left ventricular assist device (LVAD) can improve health outcomes. Researchers will monitor how well the repaired valve works post-surgery and look at patient recovery times and quality of life.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include complications from surgery such as infection or bleeding; potential worsening of heart function; reactions to anesthesia; and possible need for additional surgeries.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe heart failure and am getting an LVAD implant.
Select...
I am over 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in TR severity assessment from baseline
Secondary outcome measures
Change in RV function from baseline
Change in quality of life (QOL) from baseline
Other outcome measures
Duration of hospitalization after implant
Incidence of inotropic infusions
Incidence of serious adverse events
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: LVAD+TVRExperimental Treatment2 Interventions
In addition to left ventricular assist device (LVAD) placement with the inflow cannula in the left ventricular apex and outflow cannula placed in the ascending aorta, a repair of the regurgitating tricuspid valve will be performed. A Patent Foramen Ovale, if present, will be closed primarily. Echocardiographic parameters relevant to study will be collected throughout the procedure.
Group II: LVAD onlyActive Control1 Intervention
LVAD placement will be performed without additional tricuspid valve repair (TVR). The inflow cannula will be sutured to the left ventricular apex followed by the outflow cannula placed in the ascending aorta. This will be performed under cardiopulmonary bypass. Echocardiographic parameters relevant to study will be collected throughout the procedure.
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,726 Total Patients Enrolled
Society of Cardiovascular AnesthesiologistsUNKNOWN
2 Previous Clinical Trials
5,602 Total Patients Enrolled
Kei Togashi, MD, MPHPrincipal Investigator - University of Washington
Regents of the University of California, University of California-Irvine Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a stroke or significant blockage in my brain's blood vessels in the last 3 months.I have severe heart failure and am getting an LVAD implant.You are currently using any mechanical heart support other than an intra-aortic balloon pump.Your body weight is very high for your height.I do not want to participate in the study.I am over 18 years old.I have a mechanical aortic valve and it won't be replaced during my heart pump implant.I have had surgery to fix my tricuspid valve before.I am on long-term dialysis for my kidneys.I have an ongoing infection that isn't under control.My heart's tricuspid valve has a structural problem.I have had a heart transplant or surgery to repair my heart muscle.You have a mental health condition or cognitive issues that might make it hard for you to follow the study rules and manage a LVAD.I do not have any health conditions that could shorten my life to under a year, aside from heart failure.My liver tests show abnormal results.
Research Study Groups:
This trial has the following groups:- Group 1: LVAD+TVR
- Group 2: LVAD only
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.
How many participants may join this research study?
"Verified, clinicaltrials.gov affirms that this medical trial is still open for enrollment and was last revised on February 19th 2021. The study needs to recruit 40 patients from one participating centre."
Answered by AI
Are there any vacancies remaining in this medical trial?
"Clinicaltrials.gov reveals that this ongoing medical trial, initially posted on August 1st 2015, is still actively recruiting participants. It was most recently updated on February 19th 2021."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger