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Procedure

Tricuspid Valve Replacement for Tricuspid Regurgitation

N/A

Recruiting

Research Sponsored by Laplace Interventional, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

22 - 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30-days post-procedure

Awards & highlights

Study Summary

This trial aims to evaluate the safety and feasibility of a new system called Laplace Transcatheter Tricuspid Valve Replacement (TTVR).

Who is the study for?

This trial is for adults aged 22-90 with severe tricuspid regurgitation, a heart valve disease, who haven't improved after at least 30 days of optimal medical treatment. Candidates must be deemed suitable for the procedure by a heart team and agree to follow-up visits.Check my eligibility

What is being tested?

The study is testing the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement System, which is a new method to replace faulty heart valves without traditional surgery.See study design

What are the potential side effects?

While specific side effects are not listed here, transcatheter procedures can generally include risks such as bleeding, infection, blood vessel complications, and irregular heartbeats.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 90 years old.

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I have heart valve issues not improved by treatment for over 30 days.

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My heart valve issue is severe, as confirmed by heart scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and during procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Technical success

Secondary outcome measures

Device success

Procedural success

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tricuspid Valve ReplacementExperimental Treatment1 Intervention

Transcatheter replacement of the native tricuspid valve with the Laplace bioprosthesis

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Laplace Interventional, IncLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the clinical trial currently enrolling participants who are younger than 40 years old?

"Patients interested in taking part in this research must be at least 22 years old but no older than 90."

Answered by AI

What is the upper limit for patient enrollment in this particular clinical investigation?

"Yes, the details available on clinicaltrials.gov show that this investigation is actively seeking volunteers. It was first made public on February 19th, 2024 and last revised on February 22nd, 2024. The study aims to recruit a total of ten participants from one designated location."

Answered by AI

Are participants currently being recruited for this ongoing medical study?

"As per clinicaltrials.gov, this medical research is actively enrolling participants. The trial was initially listed on February 19th, 2024, with the latest update made on February 22nd of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06183684.

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