RecruitingNot ApplicableNCT06183684

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

Sponsor

Laplace Interventional, Inc

Enrollment

45 participants

Start Date

Feb 19, 2024

Study Type

INTERVENTIONAL

Conditions

Tricuspid Regurgitation

Summary

The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

Eligibility

Min Age: 22 YearsMax Age: 90 Years

Inclusion Criteria5

22 - 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 ICD leads, the local heart team shall include an electrophysiologist.
Subject or legally authorized representative has provided informed consent and agrees to return for all required post-procedure follow-up visits

Exclusion Criteria13

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 or leadless pacemaker within 90 days prior to the study procedure
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 <70,000 mm3 or thrombocytosis (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 investigation or to comply with follow-up requirements. Any patient considered to be vulnerable.
Left ventricular ejection fraction (LVEF) < 30%