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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 : April 11, 2024
Sponsor:
Information provided by (Responsible Party):
CroiValve Limited

Study Description
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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).

Condition or disease Intervention/treatment Phase
Tricuspid Regurgitation Tricuspid Valve Insufficiency Tricuspid Valve Disease Heart Valve Diseases Device: DUO Transcatheter Tricuspid Coaptation Valve System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Feasibility Study of the DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation
Estimated Study Start Date : April 15, 2024
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : October 2029
Arms and Interventions
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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 Name: DUO System


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05913908


Contacts
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Contact: Helen Scotch +1-612-229-9950 Helen@CroiValve.com
Contact: Aubrey Dyer +1-916-768-9141 Aubrey@CroiValve.com

Locations
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United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: Danielle Griffith       danielle.griffith@piedmont.org   
Principal Investigator: Pradeep Yadav, MD         
Principal Investigator: Vinod Thourani, MD         
United States, Illinois
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Anna Huskin       Anna.huskin@nm.org   
Principal Investigator: Charles Davidson, MD         
United States, Kansas
Cardiovascular Research Institute of Kansas Recruiting
Wichita, Kansas, United States, 67214
Contact: Lindsey Steele       lindsey.steele@cckheart.com   
Principal Investigator: Bassem Chehab, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Kara Booth       kbooth@montefiore.org   
Principal Investigator: Azeem Latib, MD         
Sponsors and Collaborators
CroiValve Limited
More Information
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Responsible Party: CroiValve Limited
ClinicalTrials.gov Identifier: NCT05913908    
Other Study ID Numbers: CV006
First Posted: June 22, 2023    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by CroiValve Limited:
Transcatheter
Coaptation Valve
TR
SVC
Tricuspid
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases