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Recruiting NCT06183684

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

No phase Interventional Tricuspid Regurgitation

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: Laplace TTVR System.
Who it may be relevant to
Registry conditions: Tricuspid Regurgitation. 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
United States
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 the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

Detailed description

Early Feasibility (EFS), prospective, single-arm, multi-center study to evaluate safety and technical feasibility of the Laplace TTVR System in the treatment of severe, symptomatic tricuspid regurgitation patients.

Interventions

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

Primary outcome measures

  • Technical success [Time frame: During procedure]
Secondary outcome measures (2)
  • Procedural success [Time frame: During procedure]
  • Device success [Time frame: 30-days post-procedure]

Eligibility criteria

Inclusion criteria

  • 18 - 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.
  • Anatomically suitable for the Laplace TTVR system (with trans-jugular or transfemoral) access
  • Subject has provided informed consent and agrees to return for all required post-procedure follow-up visits

Exclusion criteria

  • 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%
  • Contraindication or inability to complete transesophageal or intracardiac echocardiogram

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 10 centers
  • Tucson Medical Center — Tucson
  • Kaiser Permanente — San Francisco
  • Piedmont Hospital — Atlanta
  • Mayo Clinic — Rochester
  • Dartmouth-Hitchcock Medical Center — Lebanon
  • Montefiore Medical Center — The Bronx
  • University Hospitals, Cleveland Medical Center — Cleveland
  • Oklahoma Heart Institute — Tulsa
  • … and 2 more centers

Identifiers

NCT: NCT06183684 · CLN-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗