Tricuspid RegurgitationTANDEM IINCT05913908
EFS of the DUO System for Tricuspid Regurgitation
A study testing DUO Transcatheter Tricuspid Coaptation Valve System in people with Tricuspid Regurgitation and Tricuspid Valve Insufficiency, run by CroiValve Limited at 18 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
- What is being tested?
- DUO Transcatheter Tricuspid Coaptation Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 13 Aug 2024to Oct 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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
- Renal insufficiency (eGFR <25 ml/min) or currently on chronic dialysis
- Active endocarditis within 6 months of the index procedure
- Pulmonary embolism or deep vein thrombosis within the last 6 months
- Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
- Life expectancy <1 year
- Active infections requiring current antibiotic therapy
- Known severe liver disease
- Is on the waiting list for a transplant or has had a prior heart or lung transplant
- Known active peptic ulcer or active GI bleed
- Unable to take anticoagulant therapy
- Any known major coagulation abnormalities, thrombocytopenia, platelets < 50,000/ml or severe anemia Hb <8 g/dl
- Known patient is actively abusing drugs
- Any known sensitivities or allergies to contrast (that cannot be adequately premedicated) and/or the device materials, including nickel and titanium
- Patients who are pregnant or intend to become pregnant
- 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
Trial locations and contacts
18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 2 countries
United States14 sites, 14 recruiting
- Recruiting
Piedmont Heart Institute
Atlanta, Georgia, 30309
Danielle Griffith, danielle.griffith@piedmont.org
Pradeep Yadav, MD
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Gabby Urbano, 617-632-9030, gurbano@bidmc.harvard.edu
James McCabe, MD
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Anna Huskin, Anna.huskin@nm.org
Charles Davidson, MD
- Recruiting
OhioHealth Research Institute
Columbus, Ohio, 43214
Emily Sudnick
Carlos Sanchez, MD
- Recruiting
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, 17050
Brittany Mashuda, BSN, RN, CHFN, 717-782-5904, mashudabd@upmc.edu
Arun Kanmanthareddy, MD
- Recruiting
Allina Health Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Jennifer Nguyen, (612) 863-929, Jennifer.Nguyen@allina.com
Anil Poulose, MD
- Recruiting
Dignity Health St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013
Alicia Nguyen, 602-406-3544, valerie.colores@commonspirit.org
Hursh Naik, MD
- Recruiting
Baylor Scott & White - The Heart Hospital Plano
Plano, Texas, 75093
Mackenzie Gabriele, (469) 814 - 4184, Mackenzie.Gabriele@BSWHealth.org
Molly Szerlip, MD
- Recruiting
Intermountain Health
Salt Lake City, Utah, 84111
Lindsay Bosh Bosh, 801-507-4759, Lindsay.Bosh@imail.org
Brian Whisenant, MD
- Enrolling by invitation
San Antonio Methodist
San Antonio, Texas, 78229
- Recruiting
MaineHealth Institute for Research
Scarborough, Maine, 04074
Jackie LaPointe, (207)-396-8675, Jacqueline.Lapointe@mainehealth.org
Szymon Wiernek, MD
- Recruiting
University of Washington
Seattle, Washington, 98195
John Tushinski, 206-221-1665, jtushin@uw.edu
David Elison MD
- Recruiting
Los Robles Hospital & Medical Center
Thousand Oaks, California, 91360
Mane Arabyan, 805.796.3746, Mane.Arabyan@HCAHealthcare.com
Saibal Kar, MD
- Recruiting
Ascension Via Christi Research
Wichita, Kansas, 67214
Lindsey Steele, lindsey.steele@cckheart.com
Bassem Chehab, MD
Poland4 sites, 4 recruiting
- Recruiting
Medical University of Silesia
Katowice, 40-635
Wojtek Wojakowski, MD, PhD
- Recruiting
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-090
Katarzyna Łucka, 81 72 44 389, katarzyna.lucka@usk4.lublin.pl
Piotr Wacinski, MD
- Recruiting
Uniwersytetem Medycznym im. Karola Marcinkowskiego w Poznaniu
Poznan, Poznan, 60-355
Monika Szymańska, +48 793 906 017, mszymanska@ump.edu.pl
Marek Grygier
- Recruiting
Narodowym Instytutem Kardiologii Stefana Kardynała Wyszyńskiego - Państwowym Instytutem Badawczym
Warsaw, Warsaw, 04-628
Anna Pyłko, +48 785 988 045
Adam Witkowski
About this study
Official title: Early Feasibility Study of the DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation
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).
Read the 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.
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases
- Being tested
- DUO Transcatheter Tricuspid Coaptation Valve System
- Keywords
- Transcatheter, Coaptation Valve, TR, SVC, Tricuspid
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DUO Transcatheter Tricuspid Coaptation Valve SystemDevice
Also called DUO System
Reduction of tricuspid regurgitation through a transcatheter approach
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System) Receives: Device: DUO Transcatheter Tricuspid Coaptation Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start13 Aug 2024
- Primary completionDec 2027 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CroiValve Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913908
- Sponsor's protocol ID
- CV006
- Acronym
- TANDEM II
- Status last verified
- Oct 2026
- First submitted
- 31 May 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes