A Feasibility Study of the CroíValve DUO System for Tricuspid Regurgitation

NCT05296148 | Active Not Recruiting DMC

• 1 other identifier: CV005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

This study is prospective, multicentre, non-randomized single-arm early feasibility study to evaluate the safety and performance of the CroíValve DUO Transcatheter Tricuspid Coaptation Valve System in patients with severe Tricuspid Regurgitation.

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

• Freedom from device or procedure related serious adverse events

  Freedom from device or procedure related serious adverse events

  Day 30

Secondary Outcomes (3)

• Change in TR Grade

  Day 30, Month 6, Month 12

• NHYA Functional Class

  Day 30, Month 6, Month 12

• Six Minute Walk Test (6MWT)

  Day 30, Month 6, Month 12

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with the CroíValve DUO Coaptation Valve System

Device: Transcatheter Tricuspid Valve Implantation

Interventions

Transcatheter Tricuspid Valve Implantation DEVICE

Implantation of a tricuspid coaptation valve through a transcatheter approach.

Treatment

Eligibility Criteria

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

You may qualify if:

• Presence of severe Tricuspid Regurgitation per American Society of Echocardiography (ASE) Criteria determined by Echo Core Lab assessment of a qualifying Transthoracic Echocardiogram (TTE).
• Subject is symptomatic despite medical therapy (NYHA Functional Class II or higher)
• Subject is on stable medical therapy as assessed by the Heart Team
• The patient's anatomy is suitable in the judgment of the Investigational Site Heart Team and the Patient Screening Committee.
• Age ≥18 years
• The patient or the legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent on a form, as approved by the EC of the respective clinical site.

You may not qualify if:

• Subject is currently participating in another clinical investigation that could affect the outcome of this trial
• Transesophageal echocardiography (TEE) is contraindicated or unsuccessful
• Previous tricuspid valve repair, replacement or transcatheter tricuspid intervention
• Moderate to severe tricuspid valve stenosis
• Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
• Significant comorbid factors which places the subject at prohibitive risk for surgical repair in the judgment of the Investigational Site Heart Team and the Patient Screening Committee
• Need for concomitant surgical or interventional procedure known at time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).
• Ejection Fraction (EF) \<30% within 45 days of the implant procedure
• Echocardiographic or CT evidence of intracardiac mass, thrombus or vegetation
• Patient has Systolic Pulmonary Pressure (sPAP) \>60 mm Hg
• Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices
• Severe respiratory instability: Severe COPD or continuous use of home oxygen or has FEV1 \<50% of predicted
• Severe right ventricular dysfunction as determined by the Echo Core Lab
• Untreated clinically significant coronary artery disease requiring revascularization surgical or interventional PCI
• Stroke or transient ischemic event within 90 days prior to the implant procedure

Sponsors & Collaborators

• CroiValve Limited: lead

Study Sites (3)

Uniwersyteckie Centrum Kliniczne GUMed

Gdansk, Poland

Location

Górnośląskie Centrum Medyczne im. Prof. Leszka Gieca

Katowice, Poland

Location

Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńskiego

Warsaw, Poland

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

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 25, 2022
• Study Start: June 17, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

PL (3)