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New treatment option for Tricuspid Regurgitation
Official title Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients
ClinicalTrials.gov ID: NCT02537769
What this study is testing
- What it's testing
- The use of implantable left ventricular assist devices (LVAD) has increased over the last decade; partly because the newer continuous flow pumps feature a smaller design and better durability. These pumps have shown improved outcomes for those patients who don't qualify for heart transplantation and receive the LVAD device as a permanent therapy or a bridge to heart transplantation.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant or their legal representative has signed an informed consent
- Over 18 years of age
- Participant with advanced heart failure symptoms (Class III or IV) and preoperative mild tricuspid regurgitation who are scheduled for an implantable...
You likely can't join if
- Prior tricuspid valve repair
- Any evidence of structural (chordal or leaflet) tricuspid valve disease
- Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator
- Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counter pulsation
- Body Mass Index (BMI) \> 45
- Pregnancy
See the full eligibility criteria
- Participant or their legal representative has signed an informed consent
- Over 18 years of age
- Participant with advanced heart failure symptoms (Class III or IV) and preoperative mild tricuspid regurgitation who are scheduled for an implantable LVAD
- Prior tricuspid valve repair
- Any evidence of structural (chordal or leaflet) tricuspid valve disease
- Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator
- Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counter pulsation
- Body Mass Index (BMI) \> 45
- Pregnancy
- Presence of mechanical aortic valve that will not be converted to a bioprosthesis at time of LVAD implant
- History of cardiac transplant or cardiomyoplasty
- Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAD management
- Presence of active, uncontrolled infection
- Evidence of intrinsic hepatic disease as defined by liver enzyme values
- History of a stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (\> 80%) extra cranial stenosis
- Need for chronic renal replacement therapy (e.g. chronic dialysis)
- Participation in any other clinical investigation that is likely to confound study results or affect study outcome
- Any condition, other than heart failure, that could limit survival to less than 1 year
- Participant refuses to be enrolled in study
- Institution inmates.
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.