Assessing a new method for replacing the tricuspid valve in patients with severe regurgitation

Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

This study is testing a new way to replace the tricuspid valve in people with severe heart valve problems to see if it is safe and works well.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 22 Years to 90 Years
• Sex: All
• Sponsor: Laplace Interventional, Inc (industry)
• Locations: 6 sites (Tucson, Arizona and 5 other locations)
• Trial ID: NCT06183684 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System in patients suffering from severe, symptomatic tricuspid regurgitation. It is an early feasibility, prospective, single-arm, multi-center study involving multiple medical centers. Participants will undergo the TTVR procedure after being assessed by a local heart team to ensure they meet the necessary criteria for inclusion. The study aims to gather data on the effectiveness of this innovative approach to valve replacement.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 22 to 90 with severe symptomatic tricuspid regurgitation who have not responded adequately to medical therapy.

Not a fit: Patients with a life expectancy of less than 12 months or those with significant pulmonary vascular resistance may not benefit from this study.

Why it matters

Potential benefit: If successful, this procedure could provide a less invasive option for patients with severe tricuspid regurgitation, potentially improving their quality of life.

How similar studies have performed: While this approach is novel, similar transcatheter valve replacement techniques have shown promise in other studies, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. 22 - 90 years of age at the time of the study procedure
2. 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.
3. Severe, massive or torrential tricuspid regurgitation determined by qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE) using the 5-grade classification.
4. 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 ICD leads, the local heart team shall include an electrophysiologist.
5. Subject or legally authorized representative has provided informed consent and agrees to return for all required post-procedure follow-up visits

Exclusion Criteria:

1. Estimated life expectancy of less than 12 months
2. PVR \>5 Wood units
3. Echocardiographic evidence of severe right ventricular dysfunction
4. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment
5. Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
6. 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 or leadless pacemaker within 90 days prior to the study procedure
7. Stroke or other major cerebrovascular event within 90-days prior to index procedure
8. Untreated clinically significant coronary artery disease requiring revascularization, recent (within last 30 days) acute coronary syndrome or myocardial infarction.
9. Bleeding disorders including thrombocytopenia or platelet count \<70,000 mm3 or thrombocytosis (platelet count \>700,000 /mm3)
10. Current or planned pregnancy within next 12 months for women of childbearing potential
11. Active or recent endocarditis within last 90 days or, sepsis/ other systemic infection requiring oral or intravenous antibiotics within last 30 days
12. 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 investigation or to comply with follow-up requirements. Any patient considered to be vulnerable.
13. Left ventricular ejection fraction (LVEF) \< 30%

Where this trial is running

Tucson, Arizona and 5 other locations

• Tucson Medical Center — Tucson, Arizona, United States (RECRUITING)
• Kaiser Permanente — San Francisco, California, United States (RECRUITING)
• Piedmont Hospital — Atlanta, Georgia, United States (RECRUITING)
• Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
• Providence Heart Institute — Portland, Oregon, United States (RECRUITING)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)

Study contacts

• Study coordinator: Julie Messer

Conditions: Tricuspid Regurgitation