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Not yet recruiting NCT07687485

Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System

No phase Interventional Severe Tricuspid Valve Regurgitation Tricuspid Valve Regurgitation Tricuspid Valve Disease Cardiovascular Diseases (CVD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System, Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System.
Who it may be relevant to
Registry conditions: Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD). Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Detailed description

This study is a prospective, multi-center randomized (2:1) controlled pivotal trial to evaluate the safety and efficacy of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System compared to the Edwards EVOQUE TTVR System for the treatment of symptomatic subjects with severe or greater tricuspid regurgitation (TR).

Interventions

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

Primary outcome measures

  • Composite of major adverse events (MAEs) [Time frame: 30 days post-procedure]
  • Composite 12-Month Endpoint: All-cause mortality, heart failure hospitalization, tricuspid valve re-intervention [Time frame: 12 months post-procedure]
Secondary outcome measures (1)
  • Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) ≥ 10 points from baseline to 12 months [Time frame: 12 months post-procedure]

Eligibility criteria

Inclusion criteria

  • 18 - 90 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07687485 · CLN-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗