Assessing a new method for replacing the tricuspid valve in patients with severe regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System in patients suffering from severe, symptomatic tricuspid regurgitation. It is an early feasibility, prospective, single-arm, multi-center study involving multiple medical centers. Participants will undergo the TTVR procedure after being assessed by a local heart team to ensure they meet the necessary criteria for inclusion. The study aims to gather data on the effectiveness of this innovative approach to valve replacement.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 - 90 years of age at the time of the study procedure
2. 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.
3. Severe, massive or torrential tricuspid regurgitation determined by qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE) using the 5-grade classification.
4. 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.
5. Anatomically suitable for the Laplace TTVR system (with trans-jugular or transfemoral) access
6. Subject has provided informed consent and agrees to return for all required post-procedure follow-up visits

Exclusion Criteria:

1. Estimated life expectancy of less than 12 months
2. PVR \>5 Wood units
3. Echocardiographic evidence of severe right ventricular dysfunction
4. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment
5. Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
6. 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
7. Stroke or other major cerebrovascular event within 90-days prior to index procedure
8. Untreated clinically significant coronary artery disease requiring revascularization, recent (within last 30 days) acute coronary syndrome or myocardial infarction.
9. Bleeding disorders including thrombocytopenia or platelet count \<70,000 mm3 or thrombocytosis (platelet count \>700,000 /mm3)
10. Current or planned pregnancy within next 12 months for women of childbearing potential
11. Active or recent endocarditis within last 90 days or, sepsis/ other systemic infection requiring oral or intravenous antibiotics within last 30 days
12. 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.
13. Left ventricular ejection fraction (LVEF) \< 30%
14. Contraindication or inability to complete transesophageal or intracardiac echocardiogram

Where it's running

• Tucson Medical Center
  Tucson, Arizona, United States Recruiting
• Kaiser Permanente
  San Francisco, California, United States Recruiting
• Piedmont Hospital
  Atlanta, Georgia, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Dartmouth-Hitchcock Medical Center
  Lebanon, New Hampshire, United States Recruiting
• Montefiore Medical Center
  The Bronx, New York, United States Recruiting

Study contacts

• Study coordinator: Ryan Gladney
• Email: clinical@laplaceint.com
• Phone: 763-465-9501

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 3D Echocardiography to See How CIEDs May Worsen Tricuspid Regurgitation

  This study tests whether different CIEDs (leadless pacemakers, LBBaP, and conventional pacemakers) differ in causing worsening tricuspid regurgitation, using 3D heart imaging.

  Recruiting Samsung Medical Center · Seoul, Seoul · NCT07793916

• Compare leadless and left bundle branch pacemakers for heart and valve function

  This study tests whether leadless pacemakers or left bundle branch area pacing better preserve heart and tricuspid valve function in adults needing a pacemaker.

  Recruiting Guy's and St Thomas' NHS Foundation Trust · London · NCT07534917

• TriClip for treating tricuspid regurgitation in Japan

  This study will see if the TriClip device is safe and helps people in Japan with symptomatic severe tricuspid regurgitation when used in routine clinical care.

  Recruiting Abbott Medical Devices · Suita, Osaka · NCT07509658

• Impact of transcatheter tricuspid valve repair on kidneys, strength, and activity in older adults

  This study will try catheter-based tricuspid valve repair (TEER) in older adults with severe symptomatic tricuspid regurgitation to see if kidney function, fluid overload, and physical activity improve.

  Recruiting Robert Bosch Medical Center · Stuttgart · NCT07464106

• TARGET 2.0: Cardiovalve TR replacement for tricuspid regurgitation

  This study will test a percutaneously delivered Cardiovalve tricuspid replacement via the femoral vein in adults with symptomatic severe secondary tricuspid regurgitation who are high risk for open-heart surgery.

  Recruiting Cardiovalve Ltd. · Bonn · NCT07334691

• Pivot Extend device to treat severe tricuspid regurgitation

  This trial will try the Pivot Extend device in adults with severe, symptomatic tricuspid regurgitation to see if it safely reduces valve leakage and improves symptoms.

  Recruiting Tau-MEDICAL Co., Ltd. · Macquarie Park, New South Wales · NCT07172477

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.