Tricuspid RegurgitationNCT06183684
Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
A study testing Laplace TTVR System in people with Tricuspid Regurgitation, run by Laplace Interventional, Inc at 10 sites in United States.
Trial summary
The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- Laplace TTVR System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 10 sitesUnited States
- Study dates
- 19 Feb 2024to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Piedmont Hospital
Atlanta, Georgia, 30309
Amy Autry-Bush, 904-673-6220
- Recruiting
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, 44106
Nisreen Zueiter, 216-844-3801, Nisreen.Zueiter@UHhospitals.org
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Kalee Cook, 603-650-6228, Kalee.J.Cook@Hitchcock.ORG
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Temika Battle, 615-322-5036, temika.r.battle@vumc.org
- Recruiting
Providence Heart Institute
Portland, Oregon, 97225
Angela Redd, 503-216-2170, angela.redd@providence.org
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Structural Heart Research Team, 507-255-6133
- Recruiting
Kaiser Permanente
San Francisco, California, 94118
Cristina Casias, RN, 4158332247, cristina.casias@kp.org
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10641
Tammy Guzman, 718-920-4595, tamrodrigu@montefiore.org
- Recruiting
Tucson Medical Center
Tucson, Arizona, 85712
Mary Marsh, mary.marsh@tmcaz.com
- Recruiting
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
Ashlee Ritter, 918-579-5865, ashlee.smithritter@oklahomaheart.com
About this study
The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
Read the 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.
- Conditions
- Tricuspid Regurgitation
- Being tested
- Laplace TTVR System
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laplace TTVR SystemDevice
Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of severe, symptomatic tricuspid regurgitation
| Study group | Role | What they receive |
|---|---|---|
| Tricuspid Valve Replacement | Experimental | Transcatheter replacement of the native tricuspid valve with the Laplace bioprosthesis Receives: Device: Laplace TTVR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Successful valve implantation
Measured: During procedure
Secondary outcomes (2)
Procedural success
Tricuspid regurgitation of moderate or less
Measured: During procedure
Device success
Freedom from reintervention due to device related complications
Measured: 30-days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start19 Feb 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laplace Interventional, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183684
- Sponsor's protocol ID
- CLN-002
- Status last verified
- Sep 2026
- First submitted
- 7 Dec 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
- ClinicalTrials.gov ID
- NCT06183684
- Acronym / sponsor ID
- CLN-002
- Conditions
- Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Laplace Interventional, IncIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tricuspid Valve Replacement | Experimental | Device: Laplace TTVR SystemTranscatheter replacement of the native tricuspid valve with the Laplace bioprosthesis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laplace TTVR SystemTranscatheter Tricuspid Valve Replacement (TTVR) System for the treatment of severe, symptomatic tricuspid regurgitation | Device | Tricuspid Valve Replacement |
Primary outcome
Technical success
Time frame: During procedure
Successful valve implantation
2 secondary outcomes
Procedural success
Time frame: During procedure
Device success
Time frame: 30-days post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laplace TTVR System in people with Tricuspid Regurgitation, run by Laplace Interventional, Inc at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Gladney (763-465-9501, clinical@laplaceint.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.