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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05913908
Recruitment Status : Recruiting
First Posted : June 22, 2023
Last Update Posted : May 20, 2024
Sponsor:
Information provided by (Responsible Party):
CroiValve Limited

Tracking Information
First Submitted Date  ICMJE May 31, 2023
First Posted Date  ICMJE June 22, 2023
Last Update Posted Date May 20, 2024
Estimated Study Start Date  ICMJE June 2024
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2023)		 Freedom from device or procedure related MAEs [ Time Frame: At 30 days ]
  • Death
  • Reintervention
  • Disabling stroke
  • Myocardial infarction
  • Major access site and vascular complications
  • Severe bleeding
  • Renal failure requiring dialysis
  • Major cardiac structural complications
  • Pulmonary embolism
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EFS of the DUO System for Tricuspid Regurgitation (TANDEM II)
Official Title  ICMJE Early Feasibility Study of the DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation
Brief 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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Tricuspid Regurgitation
  • Tricuspid Valve Insufficiency
  • Tricuspid Valve Disease
  • Heart Valve Diseases
Intervention  ICMJE Device: DUO Transcatheter Tricuspid Coaptation Valve System
Reduction of tricuspid regurgitation through a transcatheter approach
Other Name: DUO System
Study Arms  ICMJE Experimental: Treatment
Treatment with the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System)
Intervention: Device: DUO Transcatheter Tricuspid Coaptation Valve System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2023)		 15
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE October 2029
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Helen Scotch +1-612-229-9950 Helen@CroiValve.com
Contact: Aubrey Dyer +1-916-768-9141 Aubrey@CroiValve.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05913908
Other Study ID Numbers  ICMJE CV006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party CroiValve Limited
Original Responsible Party [Redacted]
Current Study Sponsor  ICMJE CroiValve Limited
Original Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CroiValve Limited
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP