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New treatment option for Tricuspid Regurgitation
Official title TTVR Early Feasibility Study
ClinicalTrials.gov ID: NCT04433065
What this study is testing
- What it's testing
- The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
- 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
- Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic...
- Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team
- people with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a...
- New York Heart Association (NYHA) Function Class II or greater
- Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access
You likely can't join if
- Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
- Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)
- Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus
- Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude...
- Echocardiographic evidence of severe right ventricular dysfunction
- Left ventricular ejection fraction (LVEF) \<30 as measured by resting echocardiogram within 30 days of the Index Procedure
See the full eligibility criteria
- Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement
- Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team
- people with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal...
- New York Heart Association (NYHA) Function Class II or greater
- Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access
- Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
- Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
- Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
- Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)
- Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus
- Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system
- Echocardiographic evidence of severe right ventricular dysfunction
- Left ventricular ejection fraction (LVEF) \<30 as measured by resting echocardiogram within 30 days of the Index Procedure
- Need for emergent or urgent surgery
- Untreated clinically significant coronary artery disease requiring revascularization
- Carcinoid tricuspid regurgitation
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Hartford, Connecticut, United States
- Atlanta, Georgia, United States
- Ann Arbor, Michigan, United States
- Grand Rapids, Michigan, United States
- Minneapolis, Minnesota, United States
- Missoula, Montana, United States
- New York, New York, United States
- The Bronx, New York, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Harrisburg, Pennsylvania, United States
- Houston, Texas, United States
- Milwaukee, Wisconsin, 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 Birmingham, Alabama, United States; Phoenix, Arizona, United States; Los Angeles, California, United States; San Francisco, California, United States; Hartford, Connecticut, United States; Atlanta, Georgia, United States and 13 more location(s). 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.