Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2024-08-13
2029-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Treatment with the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System)
DUO Transcatheter Tricuspid Coaptation Valve System
Reduction of tricuspid regurgitation through a transcatheter approach
Interventions
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DUO Transcatheter Tricuspid Coaptation Valve System
Reduction of tricuspid regurgitation through a transcatheter approach
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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CroiValve Limited
INDUSTRY
Responsible Party
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Locations
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Dignity Health St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States
Los Robles Hospital & Medical Center
Thousand Oaks, California, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Ascension Via Christi Research
Wichita, Kansas, United States
Allina Health Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Columbia University Medical Center/NYPH
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
OhioHealth Research Institute
Columbus, Ohio, United States
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, United States
San Antonio Methodist
San Antonio, Texas, United States
Intermountain Health
Salt Lake City, Utah, United States
University of Washington
Seattle, Washington, United States
Uniwersytetem Medycznym im. Karola Marcinkowskiego w Poznaniu
Poznan, Poznan, Poland
Narodowym Instytutem Kardiologii Stefana Kardynała Wyszyńskiego - Państwowym Instytutem Badawczym
Warsaw, Warsaw, Poland
Medical University of Silesia
Katowice, , Poland
Countries
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Central Contacts
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Facility Contacts
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Mane Arabyan
Role: primary
Danielle Griffith
Role: primary
Anna Huskin
Role: primary
Lindsey Steele
Role: primary
Kate Jappe
Role: primary
Kate Dalton
Role: primary
Kara Booth
Role: primary
Emily Sudnick
Role: primary
Brittany Mashuda, BSN, RN, CHFN
Role: primary
Lindsay Bosh Bosh
Role: primary
Ray Larsen
Role: primary
Monika Szymańska
Role: primary
Anna Pyłko
Role: primary
Other Identifiers
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CV006
Identifier Type: -
Identifier Source: org_study_id