Study of Surgical Correction for Tricuspid Insufficiency in LVAD Patients
This study is looking at whether repairing a heart valve called the tricuspid valve helps patients who are receiving a Left Ventricular Assist Device (LVAD). An LVAD is a pump that helps your heart work better if you have advanced heart failure (NYHA Class III or IV). All participants will get an LVAD as part of their routine care. Half of the participants will also have a Tricuspid Valve Repair (TVR) to fix mild tricuspid regurgitation (a leaky valve). Researchers want to see if adding the TVR procedure changes how severe the tricuspid regurgitation is after 13 months. You can join if you are over 18, have advanced heart failure, and are scheduled for an LVAD. The study is currently enrolling about 30 to 40 participants.
- Study design
- This is an interventional study where participants are randomly assigned to receive either an LVAD only or an LVAD plus a Tricuspid Valve Repair (TVR). The study plans to enroll 30 to 40 participants.
- What's involved
- You will undergo a transthoracic echocardiogram within 30 days before randomization, and a medical history, physical exam, and quality of life assessment within 7 days before randomization. Randomization happens during surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, change in tricuspid regurgitation severity, is measured at 13 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients
At a glance
Conditions
NCT02537769
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Washington Medical Center
Seattle, Washingtonstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Kei Togashi, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Washington
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Change in TR severity assessment from baseline13 months
Tricuspid Regurgitation (TR) severity as measured by vena contracta width and area will be assessed using echocardiography within 7 days prior to implantation (baseline) up to 13 months postoperative. TR severity is assessed on a range of mild to severe.