RecruitingNot Applicable

Laplace Early Feasibility Study - Canada

Canada15 participantsStarted 2024-06-18

Plain-language summary

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

Who can participate

Age range

60 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. Anatomically suitable for the Laplace TTVR system including trans-jugular access 6 Subject or legally authorized representative 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
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Technical success

Timeframe: During procedure

Trial details

NCT IDNCT07171060

SponsorLaplace Interventional, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-30

Contact for this trial

Ryan Gladney

763-710-3539 clinical@laplaceint.com

View on ClinicalTrials.gov More Tricuspid Regurgitation trials