EFS of the DUO System for Tricuspid Regurgitation
TANDEM II
Early Feasibility Study of the DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation
1 other identifier
interventional
15
2 countries
15
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2024
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2023
CompletedFirst Posted
Study publicly available on registry
June 22, 2023
CompletedStudy Start
First participant enrolled
August 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2029
June 1, 2026
May 1, 2026
3.3 years
May 31, 2023
May 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Treatment
EXPERIMENTALTreatment with the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System)
Interventions
Reduction of tricuspid regurgitation through a transcatheter approach
Eligibility Criteria
You may qualify if:
- Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab.
- Patient is symptomatic despite medical therapy.
- The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention.
- The Patient's anatomy is suitable in the judgment of the Patient Selection Committee.
- Age ≥18 years
- The Patient has been informed of the nature of the study and agrees to its provisions and has provided written Informed Consent.
You may not qualify if:
- Patient is currently participating in another clinical investigation that could affect the outcome of this trial.
- Any previous tricuspid valve intervention that would interfere with the placement of the investigational device.
- Moderate or greater tricuspid valve stenosis.
- Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
- Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the investigational device.
- Need for concomitant surgical or interventional procedure, known at the time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).
- Ejection Fraction (EF) \<25%
- Echocardiographic evidence of unstable intracardiac mass, thrombus or vegetation
- Patient has Systolic Pulmonary Pressure (sPAP) \>60 mm Hg
- Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices
- Severe respiratory instability with continuous use of home oxygen
- Severe right ventricular dysfunction
- Untreated clinically significant coronary or carotid artery disease requiring revascularization surgical or interventional PCI.
- Stroke or transient ischemic event within 90 days prior to the index procedure
- Acute myocardial infarction within 30 days before the index procedure
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Dignity Health St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013, United States
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
Ascension Via Christi Research
Wichita, Kansas, 67214, United States
Allina Health Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Columbia University Medical Center/NYPH
New York, New York, 10032, United States
OhioHealth Research Institute
Columbus, Ohio, 43214, United States
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, 17050, United States
San Antonio Methodist
San Antonio, Texas, 78229, United States
Intermountain Health
Salt Lake City, Utah, 84111, United States
University of Washington
Seattle, Washington, 98195, United States
Uniwersytetem Medycznym im. Karola Marcinkowskiego w Poznaniu
Poznan, Poznan, 60-355, Poland
Narodowym Instytutem Kardiologii Stefana Kardynała Wyszyńskiego - Państwowym Instytutem Badawczym
Warsaw, Warsaw, 04-628, Poland
Medical University of Silesia
Katowice, 40-635, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2023
First Posted
June 22, 2023
Study Start
August 13, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
October 1, 2029
Last Updated
June 1, 2026
Record last verified: 2026-05