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New treatment option for Tricuspid Regurgitation
Official title Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
ClinicalTrials.gov ID: NCT06183684
What this study is testing
- What it's testing
- The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 18 - 90 years of age at the time of the study procedure
- Symptomatic tricuspid regurgitation despite being adequately treated with optimal medical therapy by the Local Heart Team for at least 30 days prior...
- Severe, massive or torrential tricuspid regurgitation determined by qualifying transthoracic echocardiogram (TTE) and/or transesophageal...
- Candidate felt suitable for transcatheter tricuspid valve replacement as determined by the local heart team and confirmed by the patient selection...
- Anatomically suitable for the Laplace TTVR system (with trans-jugular or transfemoral) access
You likely can't join if
- Estimated life expectancy of less than 12 months
- PVR \>5 Wood units
- Echocardiographic evidence of severe right ventricular dysfunction
- Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment
- Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and...
- Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery, within last 30 days. Implant or revision of any rhythm...
See the full eligibility criteria
- 18 - 90 years of age at the time of the study procedure
- Symptomatic tricuspid regurgitation despite being adequately treated with optimal medical therapy by the Local Heart Team for at least 30 days prior to the time of study consent.
- Severe, massive or torrential tricuspid regurgitation determined by qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE) using the 5-grade classification.
- Candidate felt suitable for transcatheter tricuspid valve replacement as determined by the local heart team and confirmed by the patient selection committee. For patients with pre-existing trans-tricuspid pacemaker or...
- Anatomically suitable for the Laplace TTVR system (with trans-jugular or transfemoral) access
- Subject has provided informed consent and agrees to return for all required post-procedure follow-up visits
- Estimated life expectancy of less than 12 months
- PVR \>5 Wood units
- Echocardiographic evidence of severe right ventricular dysfunction
- Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment
- Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
- Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery, within last 30 days. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator...
- Stroke or other major cerebrovascular event within 90-days prior to index procedure
- Untreated clinically significant coronary artery disease requiring revascularization, recent (within last 30 days) acute coronary syndrome or myocardial infarction.
- Bleeding disorders including thrombocytopenia or platelet count \ 700,000 /mm3)
- Current or planned pregnancy within next 12 months for women of childbearing potential
- Active or recent endocarditis within last 90 days or, sepsis/ other systemic infection requiring oral or intravenous antibiotics within last 30 days
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical...
- Left ventricular ejection fraction (LVEF) \< 30%
- Contraindication or inability to complete transesophageal or intracardiac echocardiogram
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- San Francisco, California, United States
- Atlanta, Georgia, United States
- Rochester, Minnesota, United States
- Lebanon, New Hampshire, United States
- The Bronx, New York, United States
- Cleveland, Ohio, United States
- Tulsa, Oklahoma, United States
- Portland, Oregon, United States
- Nashville, Tennessee, 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 to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; San Francisco, California, United States; Atlanta, Georgia, United States; Rochester, Minnesota, United States; Lebanon, New Hampshire, United States; The Bronx, New York, United States and 4 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.