Recruiting

TTVR System

Sponsor:

Laplace Interventional, Inc

Code:

NCT07687485

Conditions

Severe Tricuspid Valve Regurgitation

Tricuspid Valve Regurgitation

Tricuspid Valve Disease

Cardiovascular Diseases (CVD)

Heart Valve Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System

Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System

Study Details

Brief summary:

The objective of this clinical study is to assess the safety and efficacy of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of symptomatic subjects with at least severe tricuspid regurgitation (TR).

Conditions

Severe Tricuspid Valve Regurgitation

Tricuspid Valve Regurgitation

Tricuspid Valve Disease

Cardiovascular Diseases (CVD)

Heart Valve Diseases

Study ID

NCT07687485

Start date

Sep 4, 2026

Status verified date

Oct, 2026

Completion date

Sep, 2038

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 - 90 years of age at the time of the study procedure.
  • Symptomatic TR despite being adequately treated with OMT 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 echocardiogram 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.
  • Subject has provided informed consent and agrees to return for all required post-procedure follow-up visits.
  • Anatomically suitable for the Laplace TTVR system.

Exclusion Criteria:

  • Estimated life expectancy of less than 12 months.
  • Need for emergent, urgent or planned surgery or intervention within 30 days following the study procedure. Planned or scheduled cardiac surgery within next 12 months.
  • Severe renal insufficiency defined as eGFR <25 mL/min or requiring chronic renal replacement therapy at the time of screening committee review.
  • Current history (within last 5 years) of illicit drug use.
  • Stroke or other major cerebrovascular event within 90-days prior to index procedure.
  • Current or planned pregnancy within next 12 months for women of childbearing potential.
  • Participation in another pre-market investigational device study or investigational drug study for a cardiac related drug.
  • 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.
  • Anatomically unsuitable for the Laplace TTVR System

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Laplace TTVR System

Transcatheter tricuspid valve replacement with the Laplace TTVR System in patients with severe or greater TR.

active comparator: Edwards EVOQUE TTVR

Transcatheter tricuspid valve replacement with the Edwards EVOQUE TTVR in patients with severe or greater TR.

experimental: Laplace TTVR System Single Arm Cohort

Transcatheter tricuspid valve replacement with Laplace TTVR System in patients with severe or greater tricuspid regurgitation who are deemed ineligible to be treated with the Active Comparator EVOQUE TTVR and are suboptimal T-TEER candidates.

Interventions

Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System

Transcatheter Tricuspid Valve Replacement

Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System

Transcatheter Tricuspid Valve Replacement

Primary outcome measure

  • Composite of major adverse events (MAEs) [ Time Frame: 30 days post-procedure ]
  • Composite 12-Month Endpoint: All-cause mortality, heart failure hospitalization, tricuspid valve re-intervention [ Time Frame: 12 months post-procedure ]

Central Contacts and Locations

Central contacts

Ryan Gladney

763-710-3539clinical@laplaceint.com

Locations

Oklahoma Heart Institute

Recruiting

Tulsa, Oklahoma, United States, 74104

Contacts

Ashlee Ritter

918-579-5865ashlee.smithritter@oklahomaheart.com

Principal Investigator:

Kamran Muhammad

Ballad Health

Recruiting

Kingsport, Tennessee, United States, 37660

Contacts

Kristi Harkleroad

423-230-5643kristi.harkleroad@balladhealth.org

Principal Investigator:

Guarav Rana

More Information

Sponsor

Laplace Interventional, Inc

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by Laplace Interventional, Inc on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.