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

NCT06183684 | Recruiting DMC FDA Device

• 1 other identifier: CLN-002
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

• Technical success

  Successful valve implantation

  During procedure

Secondary Outcomes (2)

• Procedural success

  During procedure

• Device success

  30-days post-procedure

Study Arms (1)

Tricuspid Valve Replacement

EXPERIMENTAL

Transcatheter replacement of the native tricuspid valve with the Laplace bioprosthesis

Device: Laplace TTVR System

Interventions

Laplace TTVR System DEVICE

Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of severe, symptomatic tricuspid regurgitation

Tricuspid Valve Replacement

Eligibility Criteria

• Age: 22 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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 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%

Sponsors & Collaborators

• Laplace Interventional, Inc: lead

Study Sites (6)

Tucson Medical Center

Tucson, Arizona, 85712, United States

RECRUITING

Kaiser Permanente

San Francisco, California, 94118, United States

RECRUITING

Piedmont Hospital

Atlanta, Georgia, 30309, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Providence Heart Institute

Portland, Oregon, 97225, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Julie Messer

CONTACT

763-465-9501; clinical@laplaceint.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 27, 2023
• Study Start: February 19, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)