AzTrials
AzTrials

Tricuspid RegurgitationNCT04100720

Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation

A study testing Cardiovalve Transfemoral Tricuspid Valve in people with Tricuspid Regurgitation, run by Cardiovalve Ltd. at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral System for tricuspid valve replacement. Data collected in the clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 5 years. Read more about this study

Who is it for?
Ages 18 to 84 years
Conditions the study is for
Tricuspid Regurgitation
What is being tested?
Cardiovalve Transfemoral Tricuspid Valve
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesUnited States
Study dates
Feb 2024to Dec 2030
Phase
Interventional
Are there results?
None posted in the registry

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 to 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant is 85 ≥ Age ≥ 18 years
  • Participant has severe, symptomatic tricuspid regurgitation (TR) ≥ 3+ based upon echocardiography, as assessed by Independent core laboratory
  • Participant is New York Heart Association (NYHA) Class II-IVa
  • Participant has left ventricular ejection fraction (LVEF) ≥ 35%
  • Participant distance of 6 minute walk test (6MWT) ≥ 60 m
  • Participant adequately treated based upon medical standards, including for coronary artery disease, mitral regurgitation and Guideline Directed Medical Therapy (GDMT) for heart failure for at least 30-days prior to index procedure.
  • Acceptable by the site "Heart Team" including an interventional cardiologist, cardiothoracic surgeon, heart failure cardiologist and recommended as a candidate for the Cardiovalve System
  • Participant approved by the Subject Screening Committee

Who cannot join

  • Known significant intracardiac shunt (e.g. septal defect) or congenital structural heart disease (PFO's without significant shunts are allowed)
  • Significant coronary artery disease requiring treatment
  • Primary tricuspid disease (e.g. rheumatic, myxomatous degeneration, tricuspid valve prolapse)
  • Severe right ventricular failure per ASE guidelines1
  • Systolic pulmonary arterial pressure > 65 mmHg as assessed by transthoracic echocardiography
  • Presence of any known life threatening non-cardiac disease that will limit the subject's life expectancy to less than one year
Show all 35Show fewer
  • Cerebrovascular event (stroke, TIA) within the past 3 months
  • Active endocarditis or history of mitral/tricuspid endocarditis within the last 12 months
  • Patient has significant left sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, and aortic regurgitation or stenosis)
  • Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count <90k)
  • Documented evidence of significant renal dysfunction (eGFR<30 ml/min/1.73m2) or on any form of dialysis at time of screening within the last 4 weeks
  • Contraindication or known allergy to device's components, to anti-coagulation therapy with vitamin K antagonists or to contrast media that cannot be adequately premedicated
  • Patients unsuitable for implantation because of thrombosis of the lower venous system or presence of a vena cava filter
  • The patient has contraindication against a transesophageal echo (TEE) during the procedure
  • Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days)
  • Hepatic insufficiency (MELD > 10)
  • Female patient of child-bearing potential
  • Psychiatric or behavioral disease including known alcohol or drug abuser that is likely to impair compliance with protocol
  • Requirement for Antibiotic Treatment within the last 48 hours
  • Cardiac Anatomy deemed not suitable for the Cardiovalve Implant
  • Surgical or interventional procedure planned within 30 days prior to index procedure
  • UNOS Status 1 heart transplant or prior orthotropic heart transplantation.
  • Any prior Tricuspid valve surgery or transcatheter Tricuspid valve procedure
  • Modified Rankin Scale > 4 disability
  • Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within one month prior to index procedure
  • Need for any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of index procedure
  • Currently participating in an investigational drug or another device study which has not reached its primary endpoint
  • Patient (or legal guardian) unable or unwilling to provide written, informed consent before study enrollment
  • Chronic oral steroid or other condition that could impair healing response (e.g. cardiac sarcoidosis or other chronic inflammatory disease).
  • Acutely decompensated heart failure (i.e. hemodynamically unstable or requiring IV inotrope ) at the time of screening
  • Severe COPD or continuous use of home oxygen
  • Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
  • Aortic or pulmonic valve disease requiring surgery
  • Venous peripheral anatomy unsuitable for implant delivery
  • Chronic anemia (Hgb < 9)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Northwestern University / Bluhm Cardiovascular Institute

    Chicago, Illinois, 60611

  • Columbia University Medical Center / NYPH

    New York, New York, 10032

  • Montefiore Medical Center

    The Bronx, New York, 10461

Other trials in United States

About this study

This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral System for tricuspid valve replacement. Data collected in the clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 5 years.

Read the detailed description

The Cardiovalve Transfemoral System for tricuspid valve replacement

Data collected in the clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 5 years.

Being tested
Cardiovalve Transfemoral Tricuspid Valve
Medical subject headings
Tricuspid Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiovalve Transfemoral Tricuspid ValveDevice

    The Cardiovalve Transfemoral Tricuspid Valve System is intended for use in patients with severe, symptomatic Tricuspid regurgitation

Study groups in NCT04100720
Study groupRoleWhat they receive
Cardiovalve Transfemoral Tricuspid ValveExperimentalReplacement (Implant) delivered through a transfemoral access
Receives: Device: Cardiovalve Transfemoral Tricuspid Valve

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1. Primary Performance Endpoint - Technical Success of Cardiovalve Delivery and Function in each participant

    Cardiovalve Technical Success defined as: I Successful access, delivery and retrieval of the delivery system; II Successful deployment of correct positioning of the first intended implant; III Freedom from emergency surgery or reintervention related to the device or access procedure without any procedural mortality, stroke, and device dysfunction at 30-day follow-up.

    Measured: 30 Days

  2. Primary Performance Endpoint - Clinical Performance - Reduction in Tricuspid Regurgitation severity measured using Echocardiography and compared to baseline

    Cardiovalve Clinical Performance will be evaluated as: I The reduction in degree of tricuspid regurgitation measured immediately after the procedure compared to baseline; II The reduction in degree of tricuspid regurgitation measured at the time of discharge or 7 days post procedure, whichever comes first, in comparison with baseline

    Tricuspid Regurgitation is measured using Echocardiography and is graded based on degree of severity using grading conventions from 0 to 4+.

    0 = absent

    1. = mild
    2. = moderate
    3. = moderate to severe
    4. = severe

    Measured: 30 Days

  3. Primary Safety Endpoint (Patient Based) Participants Implanted without Major Device Related Adverse Events through thirty days

    The ability of the Cardiovalve to be implanted without Major Device Related Adverse Events through thirty (30) days including: I Death (Cardiovascular mortality vs non-cardiovascular); II Reintervention (operative or transcatheter) due to progressive or recurrent TR or device related complications; III Disabling stroke; IV Myocardial infarction (MVARC definition); V Major access site and vascular complications; VI Fatal or life-threatening bleeding (MVARC Type III-V); VII Arrhythmia and conduction disorder requiring permanent pacing; VIII Right coronary artery occlusion requiring intervention; IX Cardiac tamponade, X Renal failure requiring dialysis

    Measured: 30 Days

Secondary outcomes (6)

  1. Secondary Performance Endpoint - Tricuspid Regurgitation Severity

    Tricuspid Regurgitation is measured using Echocardiography and is graded based on degree of severity using grading conventions from 0 to 4+.

    0 = absent

    1. = mild
    2. = moderate
    3. = moderate to severe
    4. = severe

    Measured: 30 days, 3 months, 6 months

  2. Secondary Performance Endpoint - Cusp Insufficiency

    Cusp Insufficiency: Change in the degree of the cusp insufficiency as assessed with echocardiography (ordinal) from a higher to a lower value

    Measured: 30 days, 3 months, 6 months

  3. Secondary Performance Endpoint - Unrestricted Movement of Cusps

    Unrestricted Movement of Cusps: the percentage of medical devices with unrestricted movement of cusps after implantation as assessed with echocardiography

    Measured: 30 days, 3 months, 6 months

  4. Secondary Performance Endpoint - New York Heart Association (NYHA) functional class

    NYHA function class I - IV; Higher functional class represents more severe symptoms of heart failure

    NYHA Classification - The Stages of Heart Failure:

    1. Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
    2. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
    3. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.
    4. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

    Measured: 30 days, 3 months, 6 months

  5. Secondary Performance Endpoint - 6 minute walk test

    6 minute walk test distance (meters)

    Measured: 30 days, 3 months, 6 months

  6. Secondary Performance Endpoint - Kansas City Cardiomyopathy Questionnaire

    Kansas City Cardiomyopathy Questionnaire (KCCQ) - 23 subjective quality of life questions. Assessed before and after implantation. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

    There are 3 subscales: Symptom Burden - range 0-100; Physical Limitation - range 0-100; Quality of Life - range 0-100; The total KCCQ score represents the mean (average) of the three subscale scores.

    Measured: 30 days, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2019
  2. Study startFeb 2024 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2030 (estimated)

Why it stopped: COVID Impact

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04100720
Sponsor's protocol ID
CP 19-01
Status last verified
May 2026
First submitted
10 Sep 2019
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cardiovalve Transfemoral Tricuspid Valve in people with Tricuspid Regurgitation, run by Cardiovalve Ltd. at 3 sites in United States.

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 8 inclusion and 35 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: withdrawn, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1. Primary Performance Endpoint - Technical Success of Cardiovalve Delivery and Function in each participant (time frame: 30 Days). The study lists 3 primary outcomes in all. 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 NCT04100720.

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 11 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in