Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

Tricuspid Regurgitation Clinical Trial

Official title:

Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06183684
• Other study ID #: CLN-002
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: June 2030

Study information

• Verified date: February 2024
• Source: Laplace Interventional, Inc
• Contact: Julie Messer
• Phone: 763-465-9501
• Email: clinical[@]laplaceint.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2030
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 90 Years

Eligibility

Inclusion Criteria:

1. 22 - 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. Subject or legally authorized representative 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%

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• Laplace TTVR System
Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of severe, symptomatic tricuspid regurgitation

Locations

Country	Name	City	State
United States	Tucson Medical Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Laplace Interventional, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success	Successful valve implantation	During procedure
Secondary	Procedural success	Tricuspid regurgitation of moderate or less	During procedure
Secondary	Device success	Freedom from reintervention due to device related complications	30-days post-procedure