Tricuspid RegurgitationNCT05671640
Feasibility Study of the DragonFly-T System for Severe Tricuspid Regurgitation
A study testing DragonFly-T Transcatheter Tricuspid Valve Repair System in people with Tricuspid Regurgitation, run by Hangzhou Valgen Medtech Co., Ltd at 1 site in China.
Trial summary
This study is a prospective design. Patients are severe tricuspid regurgitation (TR) (≥ 3+) who remained clinically symptomatic after guideline-directed medical treatment. After signing an informed consent form, subjects are enrolled and treated with the DragonFly-T Transcatheter Tricuspid Valve 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?
- DragonFly-T Transcatheter Tricuspid Valve Repair System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2022to 10 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- In the judgment of the local cardiac team, the patient has been adequately treated according to applicable standards (including medical management), including:
- Optimal pharmacological therapy for TR (e.g. diuretics);
- Drug and/or interventional treatment of mitral regurgitation, atrial fibrillation, coronary artery disease, and heart failure;
- The Eligibility Committee confirms that the patient has received adequate medical treatment.
- Despite the drug optimization treatment according to the above method, patients still have symptoms of TR (TR grade≥3+).
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- New York Heart Association (NYHA) Cardiac function Class II-IVa.
- The patient is suitable for transcatheter tricuspid valve repair, suitable for the use of the study device, and the femoral vein access is feasible and can accommodate a 24F catheter.
- Patient must provide written informed consent before any steps related to the study.
Who cannot join
- Tricuspid valve leaflet anatomy, which may preclude clip implantation or proper clip positioning on the leaflets, including but not limited to the following:
- Evidence of calcification in the grasping area;
- Presence of a severe coaptation defect of the tricuspid leaflets;
- Severe leaflet defect(s) and cleft preventing proper device placement determined by ECL;
- Epstein anomaly.
- Previous tricuspid valve surgery or transcatheter therapy.
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- Echocardiography suggested intracardiac thrombus, tumor, or mass.
- Transthoracic Echocardiogram and Transesophageal Echocardiography are unable to evaluate tricuspid valve anatomy.
- Refractory heart failure requiring intervention (e.g., left ventricular assist device, heart transplantation) (ACC/AHA Stage D heart failure).
- Severe and uncontrolled hypertension: systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥ 110mmHg.
- Active endocarditis, active rheumatic heart disease, or rheumatic heart valvular disease leading to tricuspid valve leaf lesions (poor valve leaf compliance, perforation, etc.).
- Had myocardial infarction or unstable angina within 4 weeks; Untreated severe coronary artery stenosis requiring revascularization.
- Percutaneous coronary intervention was performed within 30 days before surgery, except for coronary angiography.
- Hemodynamic instability, defined as systolic blood pressure < 90mmHg, with or without cardiogenic shock, or requiring intra-aortic balloon counterpulsation or other hemodynamic support devices.
- Bleeding diseases or coagulation disorders, or antithrombotic drug therapy contraindications.
- Acute peptic ulcer or gastrointestinal bleeding within 3 months before surgery.
- Severe cirrhosis (Child's grade C).
- Allergy to the device material.
- Life expectancy of fewer than 12 months.
- Women who are pregnant, breastfeeding, or planning to become pregnant.
- Participated in any drug and/or medical device clinical trials within 1 month prior to the trial.
- The researchers do not consider it appropriate to be enrolled in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Jian'an Wang, MD,Phd, +8613805786328, wja@zju.edu.cn
About this study
Official title: Feasibility Study of the DragonFly-T Transcatheter Tricuspid Valve Repair System for the Treatment of Tricuspid Regurgitation
This study is a prospective design. Patients are severe tricuspid regurgitation (TR) (≥ 3+) who remained clinically symptomatic after guideline-directed medical treatment. After signing an informed consent form, subjects are enrolled and treated with the DragonFly-T Transcatheter Tricuspid Valve Repair System. All subjects receive clinical follow-up immediately after the procedure, before discharge, 30 days after the procedure, 6 months after the procedure, 12 months, and 2, 3, 4, and 5 years after the procedure.
The incidence of MAEs (Major Adverse Events) at 30 days is used as the safety endpoint. The MAEs include stroke, cardiovascular death, new renal failure, endocarditis requiring surgery, and non-elective cardiovascular interventions due to device-related adverse events.
The efficacy endpoints include acute procedural success, acute device success, the incidence of all-cause mortality and/or heart failure rehospitalization at 12 months after the procedure, the percentage of patients with tricuspid regurgitation of 2+ or less, the percentage of patients with tricuspid regurgitation reduced by at least one grade, the improvement in 6 minutes walk test, New York Heart Association (NYHA) class, quality of life change as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score and change in edema scale grading.
- Conditions
- Tricuspid Regurgitation
- Being tested
- DragonFly-T Transcatheter Tricuspid Valve Repair System
- Keywords
- Tricuspid Regurgitation
- 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.
DragonFly-T Transcatheter Tricuspid Valve Repair SystemDevice
To conduct edge-to-edge repair with DragonFly-T System under the guidance of transesophageal echocardiography.
| Study group | Role | What they receive |
|---|---|---|
| DragonFly-T Transcatheter Tricuspid Valve Repair System | Experimental | The experimental group is allocated to use a novel tricuspid valve repair system for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd. Receives: Device: DragonFly-T Transcatheter Tricuspid Valve Repair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse events (MAEs)
MAEs include stroke, cardiovascular death, new renal failure, endocarditis requiring surgery, and non-elective cardiovascular interventions due to device-related adverse events
Measured: 30 days
Secondary outcomes (9)
Acute procedural success
Successful in DragonFly-T implantation, and residual TR of 2+ or less at discharge. An echocardiography echocardiogram at 30 days can be accepted if the discharge image was not available or hard to interpret. A death before discharge or a re-operation of tricuspid valve prior to 30 days is defined as acute procedure failure
Measured: Immediately after procedure
Acute device success
One or more DragonFly-T devices are successfully delivered and released, edge-to-edge leaflet repair confirmed by echocardiogram, and successfully withdrawal of the delivery catheter
Measured: Immediately after procedure
Incidence of all-cause mortality and/or heart failure rehospitalization
Incidence of all-cause mortality and/or heart failure rehospitalization
Measured: 12 months
Tricuspid regurgitation severity
Percentage of patients with tricuspid regurgitation of 2+ or less
Measured: 30 days, 6 months, 12 months
Tricuspid regurgitation severity change
Percentage of patients with tricuspid regurgitation reduced by at least one grade
Measured: 30 days, 6 months, 12 months
Change in 6 Minutes Walk Test
Improvement in 6 Minute Walk Test
Measured: 30 days, 6 months, 12 months
Change in NYHA class
Improvement in New York Heart Association (NYHA) Function Class
Measured: 30 days, 6 months, 12 months
Quality of life improvement
Improvement in quality of life (QoL) , as measured by the Kansas City Cardiomyopathy Questionnaire
Measured: 30 days, 6 months, 12 months
Change in edema grading
Improvement in grading of edema，1-4 grade scale，higher scores mean worse outcome
Measured: 30 days, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start27 Oct 2022
- Primary completion10 Feb 2023 (estimated)
- Study completion10 Jan 2024 (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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Valgen Medtech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian'an Wang, MD,Phd, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671640
- Sponsor's protocol ID
- DragonFly-T-2
- Status last verified
- Jan 2023
- First submitted
- 20 Dec 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the DragonFly-T Transcatheter Tricuspid Valve Repair System for the Treatment of Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT05671640
- Acronym / sponsor ID
- DragonFly-T-2
- Conditions
- Tricuspid Regurgitation
- Keywords
- Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hangzhou Valgen Medtech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 10 Feb 2023 (estimated)
- Study completion
- 10 Jan 2024 (estimated)
- First posted
- 4 Jan 2023 (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.
This study is a prospective design. Patients are severe tricuspid regurgitation (TR) (≥ 3+) who remained clinically symptomatic after guideline-directed medical treatment. After signing an informed consent form, subjects are enrolled and treated with the DragonFly-T Transcatheter Tricuspid Valve Repair System. All subjects receive clinical follow-up immediately after the procedure, before discharge, 30 days after the procedure, 6 months after the procedure, 12 months, and 2, 3, 4, and 5 years after the procedure.
The incidence of MAEs (Major Adverse Events) at 30 days is used as the safety endpoint. The MAEs include stroke, cardiovascular death, new renal failure, endocarditis requiring surgery, and non-elective cardiovascular interventions due to device-related adverse events.
The efficacy endpoints include acute procedural success, acute device success, the incidence of all-cause mortality and/or heart failure rehospitalization at 12 months after the procedure, the percentage of patients with tricuspid regurgitation of 2+ or less, the percentage of patients with tricuspid regurgitation reduced by at least one grade, the improvement in 6 minutes walk test, New York Heart Association (NYHA) class, quality of life change as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score and change in edema scale grading.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DragonFly-T Transcatheter Tricuspid Valve Repair System | Experimental | Device: DragonFly-T Transcatheter Tricuspid Valve Repair SystemThe experimental group is allocated to use a novel tricuspid valve repair system for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- In the judgment of the local cardiac team, the patient has been adequately treated according to applicable standards (including medical management), including:
- Despite the drug optimization treatment according to the above method, patients still have symptoms of TR (TR grade≥3+).
- New York Heart Association (NYHA) Cardiac function Class II-IVa.
- The patient is suitable for transcatheter tricuspid valve repair, suitable for the use of the study device, and the femoral vein access is feasible and can accommodate a 24F catheter.
Key exclusion criteria (22 listed)
- Tricuspid valve leaflet anatomy, which may preclude clip implantation or proper clip positioning on the leaflets, including but not limited to the following:
- Previous tricuspid valve surgery or transcatheter therapy.
- Echocardiography suggested intracardiac thrombus, tumor, or mass.
- Transthoracic Echocardiogram and Transesophageal Echocardiography are unable to evaluate tricuspid valve anatomy.
- Refractory heart failure requiring intervention (e.g., left ventricular assist device, heart transplantation) (ACC/AHA Stage D heart failure).
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 |
|---|---|---|
| DragonFly-T Transcatheter Tricuspid Valve Repair SystemTo conduct edge-to-edge repair with DragonFly-T System under the guidance of transesophageal echocardiography. | Device | DragonFly-T Transcatheter Tricuspid Valve Repair System |
Primary outcome
Incidence of major adverse events (MAEs)
Time frame: 30 days
MAEs include stroke, cardiovascular death, new renal failure, endocarditis requiring surgery, and non-elective cardiovascular interventions due to device-related adverse events
9 secondary outcomes
Acute procedural success
Time frame: Immediately after procedure
Acute device success
Time frame: Immediately after procedure
Incidence of all-cause mortality and/or heart failure rehospitalization
Time frame: 12 months
Tricuspid regurgitation severity
Time frame: 30 days, 6 months, 12 months
Tricuspid regurgitation severity change
Time frame: 30 days, 6 months, 12 months
Change in 6 Minutes Walk Test
Time frame: 30 days, 6 months, 12 months
Change in NYHA class
Time frame: 30 days, 6 months, 12 months
Quality of life improvement
Time frame: 30 days, 6 months, 12 months
Change in edema grading
Time frame: 30 days, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- 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.
Jian'an Wang, MD,Phd principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DragonFly-T Transcatheter Tricuspid Valve Repair System in people with Tricuspid Regurgitation, run by Hangzhou Valgen Medtech Co., Ltd at 1 site in China.
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 9 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kangmu Ma (+8613341773508, makangmu@valgenmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse events (MAEs) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jan 2023.