RECRUITING

EFS of the DUO System for Tricuspid Regurgitation

Conditions

Tricuspid Regurgitation Tricuspid Valve Insufficiency Tricuspid Valve Disease Heart Valve Diseases Transcatheter Coaptation Valve TR SVC Tricuspid

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-08-13

Study Completion:2029-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05913908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Study Contact

Helen Scotch

CONTACT

612-229-9950

Helen@CroiValve.com

Aubrey Dyer

CONTACT

916-768-9141

Aubrey@CroiValve.com

Study Locations (Sites)

Los Robles Hospital & Medical Center

Thousand Oaks, California, 91360

United States

Piedmont Heart Institute

Atlanta, Georgia, 30309

United States

Northwestern University

Chicago, Illinois, 60611

United States

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67214

United States

Allina Health Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407

United States

Allina Health Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407

United States

Montefiore Medical Center

Bronx, New York, 10461

United States

Columbia University Medical Center/NYPH

New York, New York, 10032

United States

UPMC Pinnacle Harrisburg

Harrisburg, Pennsylvania, 17050

United States

Collaborators and Investigators

Sponsor: CroiValve Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-13

Study Completion Date2029-10

Study Record Updates

Study Start Date2024-08-13

Study Completion Date2029-10

Terms related to this study

Keywords Provided by Researchers

Transcatheter
Coaptation Valve
TR
SVC
Tricuspid

Additional Relevant MeSH Terms

Tricuspid Regurgitation
Tricuspid Valve Insufficiency
Tricuspid Valve Disease
Heart Valve Diseases