Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System

NCT07687485 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CLN-004
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this clinical study is to assess the safety and efficacy of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of symptomatic subjects with at least severe tricuspid regurgitation (TR).

Conditions

Severe Tricuspid Valve Regurgitation; Tricuspid Valve Regurgitation; Tricuspid Valve Disease; Cardiovascular Diseases (CVD); Heart Valve Diseases; Tricuspid Valve Insufficiency; Severe Heart Valve Disease; Symptomatic Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (2)

• Composite of major adverse events (MAEs)

  A composite of major adverse events (MAEs) at 30 days consisting of the following components: * Cardiovascular mortality * Myocardial infarction (MI) * All stroke * New need for renal replacement therapy * Severe bleeding (includes type 3b or higher as defined by Tricuspid Valve Academic Research Consortium \[TVARC\]) * Non-elective tricuspid valve re-intervention, surgery or transcatheter * Major access site and vascular complications * Major cardiac structural complications * Device-related pulmonary embolism * New arrhythmia or conduction disorder requiring permanent pacing

  30 days post-procedure

• Composite 12-Month Endpoint: All-cause mortality, heart failure hospitalization, tricuspid valve re-intervention

  12-month composite of all-cause mortality, heart failure hospitalization, tricuspid valve re-intervention

  12 months post-procedure

Secondary Outcomes (1)

• Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) ≥ 10 points from baseline to 12 months

  12 months post-procedure

Study Arms (3)

Laplace TTVR System

EXPERIMENTAL

Transcatheter tricuspid valve replacement with the Laplace TTVR System in patients with severe or greater TR.

Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System

Edwards EVOQUE TTVR

ACTIVE COMPARATOR

Transcatheter tricuspid valve replacement with the Edwards EVOQUE TTVR in patients with severe or greater TR.

Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System

Laplace TTVR System Single Arm Cohort

EXPERIMENTAL

Transcatheter tricuspid valve replacement with Laplace TTVR System in patients with severe or greater tricuspid regurgitation who are deemed ineligible to be treated with the Active Comparator EVOQUE TTVR and are suboptimal T-TEER candidates.

Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System

Interventions

Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System DEVICE

Transcatheter Tricuspid Valve Replacement

Laplace TTVR System; Laplace TTVR System Single Arm Cohort

Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System DEVICE

Transcatheter Tricuspid Valve Replacement

Edwards EVOQUE TTVR

Eligibility Criteria

• Age: 18 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 TR despite being adequately treated with OMT 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 echocardiogram 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.
• Subject has provided informed consent and agrees to return for all required post-procedure follow-up visits.
• Anatomically suitable for the Laplace TTVR system.

You may not qualify if:

• Estimated life expectancy of less than 12 months.
• 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.
• 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.
• Stroke or other major cerebrovascular event within 90-days prior to index procedure.
• Current or planned pregnancy within next 12 months for women of childbearing potential.
• Participation in another pre-market investigational device study or investigational drug study for a cardiac related drug.
• 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.
• Anatomically unsuitable for the Laplace TTVR System

Sponsors & Collaborators

• Laplace Interventional, Inc: lead

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Cardiovascular Diseases; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• Kashish Goel, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Brandon Jones, MD

  Providence St. Vincent Medical Center

  PRINCIPAL INVESTIGATOR

• Charanjit Rihal, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Gladney

CONTACT

763-710-3539; clinical@laplaceint.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will consist of two cohorts: 1. EVOQUE Eligible Cohort: 400 subjects randomized 2:1 (Laplace:EVOQUE) to demonstrate that Laplace is noninferior to EVOQUE. 2. "Suboptimal for Conventional TVI" Cohort: A single group of up to 150 subjects who are deemed suitable for the Laplace valve, deemed not suitable for EVOQUE, and deemed suboptimal for T-TEER.

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 7, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2038
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share