Laplace Early Feasibility Study - Canada

NCT07171060 | Recruiting DMC FDA Device

• 1 other identifier: CLN-003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

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: 60 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.
• Anatomically suitable for the Laplace TTVR system including trans-jugular access 6 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
• Systolic pulmonary artery pressure \> 65mmHg per TTE.
• PVR \>5 Wood units
• Acutely decompensated defined as hypotension with SBP \<90 mmHg, use of hemodynamic support devices or inotropes within the last 30 days
• Severe COPD dependent on home oxygen or chronic home oxygen use
• Echocardiographic evidence of severe right ventricular dysfunction
• Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment
• New or untreated right heart chamber or/and superior vena cava intracardiac mass, thrombus, or vegetation
• Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
• Untreatable hypersensitivity or contraindication to any of the following: Aspirin, and Clopidogrel or Ticlopidine, Heparin, and Bivalirudin, Warfarin, or DOAC, Nitinol Alloys. Severe renal insufficiency defined as eGFR \<25 mL/min or requiring chronic renal replacement therapy at the time of screening committee review.
• \. Current history (within last 5 years) of illicit drug use. 13. 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 14. Need for emergent, urgent or planned surgery or intervention within 30 days following the study procedure. Planned or scheduled cardiac surgery within next 12 months. 15. Stroke or other major cerebrovascular event within 90-days prior to index procedure 16. Untreated clinically significant coronary artery disease requiring revascularization, recent (within last 30 days) acute coronary syndrome or myocardial infarction. 17. Active or recent GI bleed within 30 days prior to study procedure or patients Contraindicated for oral anticoagulation therapy 18. Bleeding disorders including thrombocytopenia or platelet count \<70,000 mm 3 or thrombocytosis (platelet count \>700,000 /mm 3
• Transfusion dependent chronic anemia with Hb \<9/dL
• 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
• Prior tricuspid repair or tricuspid replacement or other device that would interfere with successful deployment or functioning of Laplace tricuspid valve.

Sponsors & Collaborators

• Laplace Interventional, Inc: lead

Study Sites (1)

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Ryan Gladney

CONTACT

763-710-3539; clinical@laplaceint.com

Study Design

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

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 12, 2025
• Study Start: June 18, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2031
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)