Health TrialsbyHealthPanel

Laplace Early Feasibility Study - Canada

ConditionTricuspid Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorLaplace Interventional, Inc

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

60 - 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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Laplace TTVR System

    Device

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

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Tricuspid Valve ReplacementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Technical success

Successful valve implantation

Time frame
During procedure

Secondary outcomes

1

Procedural success

Tricuspid regurgitation of moderate or less

Time frame
During procedure
2

Device success

Freedom from reintervention due to device related complications

Time frame
30-days post-procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laplace Interventional, Inc

Lead sponsor

Source ClinicalTrials.gov
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