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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
Are there results?
Not yet: the study is under way

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).
Show all 31Show fewer
  • 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.

Helen Scotch contact

612-229-9950

Helen@CroiValve.com

Aubrey Dyer contact

916-768-9141

Aubrey@CroiValve.com

18 sites in 2 countries

United States14 sites, 14 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

    Recruiting

  • San Antonio Methodist

    San Antonio, Texas, 78229

    Enrolling by invitation

  • 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

    Recruiting

Other trials in United States

Poland4 sites, 4 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

    Recruiting

Other trials in Poland

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.

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 groups in NCT05913908
Study groupRoleWhat they receive
TreatmentExperimentalTreatment 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.

  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

    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.

  1. First posted22 Jun 2023
  2. Study start13 Aug 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionOct 2029 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Helen Scotch (612-229-9950, Helen@CroiValve.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from device or procedure related MAEs (time frame: At 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05913908.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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