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Procedure

TTVR System 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
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during procedure
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need treatment for severe heart valve issues.
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I have a serious heart condition present from birth.
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I have not had heart or carotid surgery, or any device implants in the last 30 to 90 days.
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I haven't had recent heart issues or untreated heart artery problems.
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I do not have a bleeding disorder or abnormal platelet counts.
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I have not had a stroke or major brain event in the last 3 months.
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I haven't had heart infection or any serious infection needing antibiotics in the last 3 months.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Technical success
Secondary study objectives
Device success
Procedural success

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tricuspid Valve ReplacementExperimental Treatment1 Intervention
Transcatheter replacement of the native tricuspid valve with the Laplace bioprosthesis

Find a Location

Who is running the clinical trial?

Laplace Interventional, IncLead Sponsor
~2 spots leftby Mar 2025
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