Tricuspid RegurgitationNCT03382457
Clinical Study of Edwards Cardioband FIT Valve Repair System
A study testing Transcatheter Tricuspid Valve Repair in people with Tricuspid Regurgitation, run by Edwards Lifesciences at 9 sites in United States.
Trial summary
Clinical Study of the Edwards Cardioband FIT Repair System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- Transcatheter Tricuspid Valve Repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Jul 2018to 31 Dec 2031
- 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
- Tricuspid regurgitation (moderate or greater)
- Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
- The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid reconstruction
- Patient is willing and able to comply with all specified study evaluations and provides written informed consent
Who cannot join
- Patients with conditions or anatomical considerations that preclude safe and successful procedure-related or study device access, deployment, or function, including but not limited to:
- Patients in whom transesophageal echocardiography is contraindicated or cannot be completed.
- Patients in whom tricuspid valve anatomy is not evaluable by TTE or TEE
- Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), polyester, or contrast media.
- Previous tricuspid valve repair or replacement with device in place
- Presence of trans-tricuspid pacemaker or defibrillator leads where: (a)TR is a result of impingement on the tricuspid valve leaflet as evaluated by echocardiography; or (b) implanted in the RV within the last 90 days
Show all 30Show fewer
- Primary tricuspid valve disease
- Any physical impairment which limits the patient's capacity to complete functional testing due to other medical conditions independent of their TR (e.g., orthopedic condition)
- Currently participating in another investigational biologic, drug, or device study
- Any of the following cardiovascular procedures:
- Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days
- Carotid surgery within the last 30 days
- Direct current cardioversion within the last 30 days
- Leadless RV pacemaker implant within the last 30 days
- Cardiac surgery within the last 90 days
- Any of the following underlying medical conditions:
- Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
- Active endocarditis or infection requiring antibiotic therapy (oral or intravenous)
- Hemodynamically significant pericardial effusion
- Significant intra-cardiac mass, thrombus, or vegetation
- Untreated clinically significant coronary artery disease (CAD) requiring revascularization, evidence of acute coronary syndrome, or recent myocardial infarction (MI)
- Known history of untreated severe symptomatic carotid stenosis (>50% by ultrasound) or asymptomatic carotid stenosis (>70% by ultrasound)
- Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or hemodynamic support within the last 30 days
- Known bleeding or clotting disorders or patient refuses blood transfusion
- Active GI bleeding
- Recent stroke
- Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months or any planned percutaneous cardiac procedure within the next 90 days
- Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 6 months
- Pregnant, breastfeeding, or planning pregnancy within the next 12 months
- Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Virginia Health System
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
Morristown Medical Center
Morristown, New Jersey, 07962
Intermountain Medical Center
Murray, Utah, 84107
Columbia University Medical Center /New York Presbyterian Hospital
New York, New York, 10032
Heart Hospital Baylor Plano
Plano, Texas, 75093
Oregon Health & Science University
Portland, Oregon, 97293
Mayo Clinic
Rochester, Minnesota, 55905
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
About this study
Clinical Study of the Edwards Cardioband FIT Repair System
Read the detailed description
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards Cardioband FIT Repair System
- Conditions
- Tricuspid Regurgitation
- Being tested
- Transcatheter Tricuspid Valve Repair
- Keywords
- Functional, TR, FTR, Transcatheter, Repair
- 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.
Transcatheter Tricuspid Valve RepairDevice
Also called Edwards Cardioband Tricuspid Valve Repair
Repair of the tricuspid valve through a transcatheter approach
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with the Edwards Cardioband FIT Repair System Receives: Device: Transcatheter Tricuspid Valve Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint -Composite Major Adverse Event (MAE) Rate
Number and percentage of patients who experienced at least one major adverse event (MAE).
Measured: 30 days
Primary Performance Endpoint - Intraprocedural Success
Number of patients who had Intraprocedural Success, definition modified from TVARC criteria. Per patient analysis.
Measured: Intraprocedural
Primary Performance Endpoint - Clinical Success
Number of patients who had Clinical Success at 30 days and 1 year, definition modified from TVARC criteria. Per patient analysis.
Measured: 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 Jul 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Gray, MD, Principal investigator, Lankenau HeartFiras Zahr, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382457
- Sponsor's protocol ID
- 2017-19
- Status last verified
- May 2026
- First submitted
- 19 Dec 2017
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Davidson CJ, Abramson S, Smith RL, Kodali SK, Kipperman RM, Eleid MF, Reisman M, Whisenant BK, Puthumana J, Fowler D, Grayburn PA, Hahn RT, Koulogiannis K, Pislaru SV, Zwink T, Minder M, Deuschl F, Feldman T, Gray WA, Lim DS; Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study Investigators. Transcatheter Tricuspid Repair With the Use of 4-Dimensional Intracardiac Echocardiography. JACC Cardiovasc Imaging. 2022 Mar;15(3):533-538. doi: 10.1016/j.jcmg.2021.01.029. Epub 2021 Mar 17. No abstract available.
PubMed 33744150Davidson CJ, Lim DS, Smith RL, Kodali SK, Kipperman RM, Eleid MF, Reisman M, Whisenant B, Puthumana J, Abramson S, Fowler D, Grayburn P, Hahn RT, Koulogiannis K, Pislaru SV, Zwink T, Minder M, Dahou A, Deo SH, Vandrangi P, Deuschl F, Feldman TE, Gray WA; Cardioband TR EFS Investigators. Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes. JACC Cardiovasc Interv. 2021 Jan 11;14(1):41-50. doi: 10.1016/j.jcin.2020.10.017.
PubMed 33413863
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Edwards Cardioband FIT Valve Repair System
- ClinicalTrials.gov ID
- NCT03382457
- Acronym / sponsor ID
- 2017-19
- Conditions
- Tricuspid Regurgitation
- Keywords
- Functional, TR, FTR, Transcatheter, Repair
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Study of the Edwards Cardioband FIT Repair System
Detailed description
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards Cardioband FIT Repair System
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Transcatheter Tricuspid Valve RepairTreatment with the Edwards Cardioband FIT Repair System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Tricuspid regurgitation (moderate or greater)
- Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
- The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid reconstruction
- Patient is willing and able to comply with all specified study evaluations and provides written informed consent
Key exclusion criteria (30 listed)
- Patients with conditions or anatomical considerations that preclude safe and successful procedure-related or study device access, deployment, or function, including but not limited to:
- Patients in whom transesophageal echocardiography is contraindicated or cannot be completed.
- Patients in whom tricuspid valve anatomy is not evaluable by TTE or TEE
- Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), polyester, or contrast media.
- Previous tricuspid valve repair or replacement with device in place
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Tricuspid Valve RepairAlso: Edwards Cardioband Tricuspid Valve RepairRepair of the tricuspid valve through a transcatheter approach | Device | Treatment |
Primary outcome
Primary Safety Endpoint -Composite Major Adverse Event (MAE) Rate
Time frame: 30 days
Number and percentage of patients who experienced at least one major adverse event (MAE).
Primary Performance Endpoint - Intraprocedural Success
Time frame: Intraprocedural
Number of patients who had Intraprocedural Success, definition modified from TVARC criteria. Per patient analysis.
Primary Performance Endpoint - Clinical Success
Time frame: 30 days and 1 year
Number of patients who had Clinical Success at 30 days and 1 year, definition modified from TVARC criteria. Per patient analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 33744150Davidson CJ, Abramson S, Smith RL, Kodali SK, Kipperman RM, Eleid MF, Reisman M, Whisenant BK, Puthumana J, Fowler D, Grayburn PA, Hahn RT, Koulogiannis K, Pislaru SV, Zwink T, Minder M, Deuschl F, Feldman T, Gray WA, Lim DS; Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study Investigators. Transcatheter Tricuspid Repair With the Use of 4-Dimensional Intracardiac Echocardiography. JACC Cardiovasc Imaging. 2022 Mar;15(3):533-538. doi: 10.1016/j.jcmg.2021.01.029. Epub 2021 Mar 17. No abstract available.
- Derived from this study: PubMed 33413863Davidson CJ, Lim DS, Smith RL, Kodali SK, Kipperman RM, Eleid MF, Reisman M, Whisenant B, Puthumana J, Abramson S, Fowler D, Grayburn P, Hahn RT, Koulogiannis K, Pislaru SV, Zwink T, Minder M, Dahou A, Deo SH, Vandrangi P, Deuschl F, Feldman TE, Gray WA; Cardioband TR EFS Investigators. Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes. JACC Cardiovasc Interv. 2021 Jan 11;14(1):41-50. doi: 10.1016/j.jcin.2020.10.017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Gray, MD principal investigator
Lankenau Heart
Firas Zahr, MD principal investigator
Oregon Health and Science University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Tricuspid Valve Repair in people with Tricuspid Regurgitation, run by Edwards Lifesciences at 9 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 4 inclusion and 30 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: under way, not looking for participants, as of the sponsor's last update on 8 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 9 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?
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?
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?
Primary Safety Endpoint -Composite Major Adverse Event (MAE) Rate (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 NCT03382457, which also lists 2 linked publications.
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 8 May 2026.