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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Heart Valve Diseases; Tricuspid Valve Insufficiency; Tricuspid Regurgitation; Tricuspid Valve Disease
• Intervention / Treatment: Device: DUO Transcatheter Tricuspid Coaptation Valve System

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helen Scotch; Phone Number: +1-612-229-9950; Email: Helen@CroiValve.com
• Study Contact Backup: Name: Aubrey Dyer; Phone Number: +1-916-768-9141; Email: Aubrey@CroiValve.com

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • Piedmont Heart Institute
      • Principal Investigator: Pradeep Yadav, MD
      • Principal Investigator: Vinod Thourani, MD
      • Contact: Danielle Griffith; Email: danielle.griffith@piedmont.org
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Not yet recruiting
      • Northwestern University
      • Principal Investigator: Charles Davidson, MD
      • Contact: Anna Huskin; Email: Anna.huskin@nm.org
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Recruiting
      • Cardiovascular Research Institute of Kansas
      • Principal Investigator: Bassem Chehab, MD
      • Contact: Lindsey Steele; Email: lindsey.steele@cckheart.com
  • New York
    • Bronx, New York, United States, 10461
      • Recruiting
      • Montefiore Medical Center
      • Contact: Kara Booth; Email: kbooth@montefiore.org
      • Principal Investigator: Azeem Latib, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Treatment with the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System)	Device: DUO Transcatheter Tricuspid Coaptation Valve System; Reduction of tricuspid regurgitation through a transcatheter approach; Other Names: DUO System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CroiValve Limited

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Transcatheter; Tricuspid; TR; Coaptation Valve; SVC
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: CV006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes