Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
24. september 2026 opdateret af: Laplace Interventional, Inc
The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
65
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ryan Gladney
- Telefonnummer: 763-465-9501
- E-mail: clinical@laplaceint.com
Studiesteder
-
-
Arizona
-
Tucson, Arizona, Forenede Stater, 85712
- Rekruttering
- Tucson Medical Center
-
Kontakt:
- Mary Marsh
- E-mail: mary.marsh@tmcaz.com
-
-
California
-
San Francisco, California, Forenede Stater, 94118
- Rekruttering
- Kaiser Permanente
-
Kontakt:
- Cristina Casias, RN
- Telefonnummer: 4158332247
- E-mail: cristina.casias@kp.org
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30309
- Rekruttering
- Piedmont Hospital
-
Kontakt:
- Amy Autry-Bush
- Telefonnummer: 904-673-6220
-
-
Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905
- Rekruttering
- Mayo Clinic
-
Kontakt:
- Structural Heart Research Team
- Telefonnummer: 507-255-6133
-
-
New Hampshire
-
Lebanon, New Hampshire, Forenede Stater, 03756
- Rekruttering
- Dartmouth-Hitchcock Medical Center
-
Kontakt:
- Kalee Cook
- Telefonnummer: 603-650-6228
- E-mail: Kalee.J.Cook@Hitchcock.ORG
-
-
New York
-
The Bronx, New York, Forenede Stater, 10641
- Rekruttering
- Montefiore Medical Center
-
Kontakt:
- Tammy Guzman
- Telefonnummer: 718-920-4595
- E-mail: tamrodrigu@montefiore.org
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44106
- Rekruttering
- University Hospitals, Cleveland Medical Center
-
Kontakt:
- Nisreen Zueiter
- Telefonnummer: 216-844-3801
- E-mail: Nisreen.Zueiter@UHhospitals.org
-
-
Oklahoma
-
Tulsa, Oklahoma, Forenede Stater, 74104
- Rekruttering
- Oklahoma Heart Institute
-
Kontakt:
- Ashlee Ritter
- Telefonnummer: 918-579-5865
- E-mail: ashlee.smithritter@oklahomaheart.com
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97225
- Rekruttering
- Providence Heart Institute
-
Kontakt:
- Angela Redd
- Telefonnummer: 503-216-2170
- E-mail: angela.redd@providence.org
-
-
Tennessee
-
Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Vanderbilt University Medical Center
-
Kontakt:
- Temika Battle
- Telefonnummer: 615-322-5036
- E-mail: temika.r.battle@vumc.org
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Tricuspid Valve Replacement
Transcatheter replacement of the native tricuspid valve with the Laplace bioprosthesis |
Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of severe, symptomatic tricuspid regurgitation |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Technical success
Tidsramme: During procedure
|
Successful valve implantation |
During procedure
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Procedural success
Tidsramme: During procedure
|
Tricuspid regurgitation of moderate or less |
During procedure
|
|
Device success
Tidsramme: 30-days post-procedure
|
Freedom from reintervention due to device related complications |
30-days post-procedure
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
19. februar 2024
Primær færdiggørelse (Anslået)
1. december 2027
Studieafslutning (Anslået)
1. december 2032
Datoer for studieregistrering
Først indsendt
7. december 2023
Først indsendt, der opfyldte QC-kriterier
14. december 2023
Først opslået (Faktiske)
27. december 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CLN-002
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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