A Feasibility Study of the CroíValve DUO System for Tricuspid Regurgitation

Tricuspid Regurgitation Clinical Trial

— TANDEM I  

Official title:

A European Feasibility Study of the CroíValve DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05296148
• Other study ID #: CV005
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: November 2022
• Source: CroiValve Limited
• Contact: Helen Scotch
• Phone: 612 229 9950
• Email: clinicaltrials[@]croivalve.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Presence of severe Tricuspid Regurgitation per American Society of Echocardiography (ASE) Criteria determined by Echo Core Lab assessment of a qualifying Transthoracic Echocardiogram (TTE).

2. Subject is symptomatic despite medical therapy (NYHA Functional Class II or higher)

3. Subject is on stable medical therapy as assessed by the Heart Team

4. The patient's anatomy is suitable in the judgment of the Investigational Site Heart Team and the Patient Screening Committee.

5. Age =18 years

6. 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.

Exclusion Criteria:

1. Subject is currently participating in another clinical investigation that could affect the outcome of this trial

2. Transesophageal echocardiography (TEE) is contraindicated or unsuccessful

3. Previous tricuspid valve repair, replacement or transcatheter tricuspid intervention

4. Moderate to severe tricuspid valve stenosis

5. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation

6. 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

7. Need for concomitant surgical or interventional procedure known at time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).

8. Ejection Fraction (EF) <30% within 45 days of the implant procedure

9. Echocardiographic or CT evidence of intracardiac mass, thrombus or vegetation

10. Patient has Systolic Pulmonary Pressure (sPAP) >60 mm Hg

11. Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices

12. Severe respiratory instability: Severe COPD or continuous use of home oxygen or has FEV1 <50% of predicted

13. Severe right ventricular dysfunction as determined by the Echo Core Lab

14. Untreated clinically significant coronary artery disease requiring revascularization surgical or interventional PCI

15. Stroke or transient ischemic event within 90 days prior to the implant procedure

16. Untreated severe symptomatic carotid stenosis (>70% by ultrasound)

17. Acute myocardial infarction within 30 days before the index procedure

18. Renal insufficiency (eGFR<25 ml/min)

19. Active endocarditis within 6 months of the implant procedure

20. Pulmonary embolism within the last 6 months

21. Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure

22. Patient has an SVC dimension/anatomy is not suitable for device implantation (i.e., extremely tortuous, heavily calcified, aneurysmal)

23. Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis

24. Life expectancy <1 year

25. Active infections requiring current antibiotic therapy

26. Known severe liver disease

27. Prior heart or lung transplant

28. Known active peptic ulcer or active GI bleed

29. Unable to take anticoagulant therapy

30. Known patient is actively abusing drugs

31. Subjects who are pregnant or planning to become pregnant

32. Any condition making it unlikely the subject will be able to complete all protocol procedures (including compliance with guideline-directed medical therapy and immobility that would prevent completion of 6MWT), follow-up visits, or impact the scientific soundness of the clinical investigation result

33. Any known major coagulation abnormalities, thrombocytopenia, platelets <50,0000/ml or anemia Hb <9g/dl

34. Any known sensitivities or allergies to contrast and/or the device materials, including nickel and titanium

35. BMI >50kg/m2

36. Transvalvular implanted pacemaker or ICD lead is present

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• Transcatheter Tricuspid Valve Implantation
Implantation of a tricuspid coaptation valve through a transcatheter approach.

Locations

Country	Name	City	State
Poland	Uniwersyteckie Centrum Kliniczne GUMed	Gdansk
Poland	Górnoslaskie Centrum Medyczne im. Prof. Leszka Gieca	Katowice
Poland	Narodowy Instytut Kardiologii im. Stefana kardynala Wyszynskiego	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
CroiValve Limited

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from device or procedure related serious adverse events	Freedom from device or procedure related serious adverse events	Day 30
Secondary	Change in TR Grade	Number of patients with reduction in TR from baseline as assessed by echocardiography	Day 30, Month 6, Month 12
Secondary	NHYA Functional Class	Number of patients with improvement in NYHA class	Day 30, Month 6, Month 12
Secondary	Six Minute Walk Test (6MWT)	Change in distance (m) from baseline	Day 30, Month 6, Month 12