EFS of the DUO System for Tricuspid Regurgitation (TANDEM II)

Heart Valve Diseases Clinical Trial

— TANDEM II  

Official title:

Early Feasibility Study of the DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913908
• Other study ID #: CV006
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: October 2029

Study information

• Verified date: April 2024
• Source: CroiValve Limited
• Contact: Helen Scotch
• Phone: +1-612-229-9950
• Email: Helen[@]CroiValve.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).

Description:

Multi-center, prospective, non-randomized, investigational, and pre-market. Data collected in this clinical study will include safety and function of the investigational system as well as up to 5 year clinical outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 2029
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab.

2. Patient is symptomatic despite medical therapy.

3. The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention.

4. The Patient's anatomy is suitable in the judgment of the Patient Selection Committee.

5. Age =18 years

6. The Patient has been informed of the nature of the study and agrees to its provisions and has provided written Informed Consent.

Exclusion Criteria:

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

2. Any previous tricuspid valve intervention that would interfere with the placement of the investigational device.

3. Moderate or greater tricuspid valve stenosis.

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

5. Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the investigational device.

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

7. Ejection Fraction (EF) <25%

8. Echocardiographic evidence of unstable intracardiac mass, thrombus or vegetation

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

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

11. Severe respiratory instability with continuous use of home oxygen

12. Severe right ventricular dysfunction

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

14. Stroke or transient ischemic event within 90 days prior to the index procedure

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

16. Renal insufficiency (eGFR <25 ml/min) or currently on chronic dialysis

17. Active endocarditis within 6 months of the index procedure

18. Pulmonary embolism or deep vein thrombosis within the last 6 months

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

20. Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis

21. Life expectancy <1 year

22. Active infections requiring current antibiotic therapy

23. Known severe liver disease

24. Is on the waiting list for a transplant or has had a prior heart or lung transplant

25. Known active peptic ulcer or active GI bleed

26. Unable to take anticoagulant therapy

27. Any known major coagulation abnormalities, thrombocytopenia, platelets < 50,000/ml or severe anemia Hb <8 g/dl

28. Known patient is actively abusing drugs

29. Any known sensitivities or allergies to contrast (that cannot be adequately premedicated) and/or the device materials, including nickel and titanium

30. Patients who are pregnant or intend to become pregnant

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

Related Conditions & MeSH terms

• Heart Valve Diseases
• Tricuspid Regurgitation
• Tricuspid Valve Disease
• Tricuspid Valve Insufficiency

Intervention

Device:
• DUO Transcatheter Tricuspid Coaptation Valve System
Reduction of tricuspid regurgitation through a transcatheter approach

Locations

Country	Name	City	State
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Montefiore Medical Center	Bronx	New York
United States	Northwestern University	Chicago	Illinois
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
CroiValve Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from device or procedure related MAEs	Death; Reintervention; Disabling stroke; Myocardial infarction; Major access site and vascular complications; Severe bleeding; Renal failure requiring dialysis; Major cardiac structural complications; Pulmonary embolism	At 30 days