Actively Recruiting
Trisol System EFS Study
Led by Trisol Medical · Updated on 2025-11-21
30
Participants Needed
7
Research Sites
486 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).
CONDITIONS
Official Title
Trisol System EFS Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Legal age to provide informed consent according to local regulations
- Symptomatic moderate or greater functional or degenerative tricuspid regurgitation confirmed by echocardiogram
- New York Heart Association Functional Class II to IVa
- Considered high surgical risk or greater for tricuspid valve surgery and suitable for transcatheter valve replacement
- Adequately treated according to medical standards including coronary artery disease, mitral regurgitation, and heart failure therapy for at least 30 days prior
- Male or non-pregnant female
- Understands the procedure and provides written informed consent
- Willing and able to comply with study requirements and follow-up
- Anatomically suitable for the Trisol system and approved by the screening committee
You will not qualify if you...
- Previous tricuspid valve repair or replacement that may affect device delivery or deployment
- Stroke or transient ischemic event within the past 90 days
- Acute myocardial infarction within the past 90 days
- Hemodynamic instability requiring inotropic therapy or mechanical support
- Untreated significant coronary artery disease requiring revascularization
- Implant or revision of rhythm management device or defibrillator within past 30 days
- New or untreated intracardiac mass, thrombus, or vegetation in right heart chambers or superior vena cava
- Systolic pulmonary arterial pressure over 80 mmHg
- Severe right ventricular dysfunction with specific measured indices
- Ongoing sepsis or active endocarditis
- Active infection requiring antibiotics
- Known bleeding disorders or blood dyscrasias
- Active gastrointestinal bleeding or history within past 60 days
- Left ventricular ejection fraction below 25%
- Contraindication to transesophageal echocardiography
- Severe aortic, mitral, or pulmonary valve disease requiring intervention or recent surgery
- Severe tricuspid valve stenosis
- Need for cardiovascular or carotid surgery within 30 days
- Need for urgent non-cardiac surgery
- Allergy or contraindication to device components, vitamin K antagonists, or contrast media
- History of cardiac transplantation or listed for urgent transplant
- Life-threatening non-cardiac disease limiting life expectancy to less than one year
- Contraindication or hypersensitivity to anticoagulant or antiplatelet therapy
- Unsuitable venous anatomy for implant delivery
- Presence of pacemaker or ICD lead preventing valve placement
- Active COVID-19 infection
- Other comorbid conditions limiting study participation or scientific integrity
- Previously enrolled in this or interfering investigational studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Actively Recruiting
3
Columbia University Medical Center/NYPH
New York, New York, United States, 10032
Actively Recruiting
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
5
Main Line Health / Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States, 19096
Not Yet Recruiting
6
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
7
University of Virginia Cardiology
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
R
Ron Davidson, B. Sc., MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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