Innoventric Trillium™ Stent Graft First-in-Human (FIH) Study

NCT04289870 | Active Not Recruiting

• 1 other identifier: CLD-001
• Study Type: interventional
• Target: 20
• Locations: 4 countries
• Sites: 9

Brief Summary

A prospective, single-arm, multi-center first-in-human (FIH) study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft System. Twenty (20) patients in 8 investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, after 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, and 3 years following the index procedure.

Conditions

Tricuspid Regurgitation

Keywords

Tricuspid Valve; Tricuspid Valve Insufficiency; Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (3)

• Safety Endpoint

  Rate of device or procedure-related MAEs and Freedom from unplanned surgery or re-intervention, due to life-threatening device or procedure failure

  Evaluated immediately after intervention, discharge and 30 days

• Technical performance

  Successful access, delivery, and retrieval of the Trillium delivery system, the device is anchored both in SVC and IVC.

  Evaluated immediately after intervention

• Efficacy Endpoint

  TR grade as measured on the device valves (Echocardiography), or by hepatic vein systolic backflow (Echocardiography), or reduction in peak central venous pressure (Invasive hemodynamic measurement).

  Evaluated immediately after intervention

Secondary Outcomes (2)

• Safety Endpoint

  Assessment at 3-month, 6-month and 1-year

• Efficacy Endpoint

  Assessment at 30 days, 3-month, 6-month and 1-year

Other Outcomes (1)

• Other Endpoints

  Assessment at 30 days, 3-month, 6-month and 1-year

Study Arms (1)

Innoventric Trillium™ Stent Graft Single Arm

EXPERIMENTAL

Single-arm, open label, multi-center study

Device: Trillium™

Interventions

Trillium™ DEVICE

Trillium™ Stent Graft for Functional Tricuspid Valve Replacement

Innoventric Trillium™ Stent Graft Single Arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled patients must meet ALL the following criteria:
• Age \>40 (no upper limit)
• Patient has clinically significant TR graded as severe based on the presence of systolic hepatic vein flow reversal, and VCW≥7mm or EROA≥40mm\^2
• Symptomatic despite medical therapy; patient must be on diuretic therapy.
• Peak central venous pressure of ≥ 15mmHg
• The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid intervention
• Patient is willing and able to comply with all specified study evaluations.
• Patient has NYHA functional classification of III or IV
• Patient is not eligible for standard-of-care surgical or interventional therapy assessed by the central heart team or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic
• Patient understands the nature of the study and study requirements and is willing to provide written Informed Consent prior to any study-specific procedures.

You may not qualify if:

• Patients will be excluded from participation if ANY of the following criteria apply:
• Echocardiographic parameters (Any of the following):
• I. LVEF \< 20% II. Evidence of severe right ventricular dysfunction (e.g. right ventricular TAPSE \< 13.0mm) III. IVC or SVC anatomy that precludes proper device deployment and function
• Systolic Pulmonary Artery Pressure \> 70mmHg
• Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
• Active endocarditis within 90 days of the scheduled implant
• Significant pericardial effusion
• Intra-cardiac masses, thrombi, or vegetation
• Thrombosis of the venous system
• Space-consuming lesion in the heart or on the valves, thrombus, or microbial colonization of the valves
• Untreated clinically significant coronary artery disease requiring immediate revascularization
• MI or known unstable angina within 30 days prior to the index procedure
• Any therapeutic invasive cardiac procedure within 30 days prior to the index procedure
• Any prior cardiac surgery, within 3 months of the index procedure
• Hemodynamic instability or treated with IV inotropes within 30 days of the index procedure

Sponsors & Collaborators

• Innoventric LTD: lead

Study Sites (9)

OLVZ Aalst

Aalst, Belgium

Location

ZNA

Antwerp, Belgium

Location

Heart & Diabetes Center NRW

Bad Oeynhausen, 32545, Germany

Location

Herzzentrum der Charité (DHZC)

Berlin, Germany

Location

Leipzig Heart Center

Leipzig, Germany

Location

Rabin Medical Center

Petah Tikva, 4941492, Israel

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Hospital Alvaro Cunqueiro, Hospital Universitario de Vigo

Vigo, Spain

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: First In Human study

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 28, 2020
• Study Start: June 24, 2020
• Primary Completion: July 21, 2023
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

IL (1); BE (2); ES (3); DE (3)