Tricuspid RegurgitationNCT05556460
Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation
A study testing DragonFly-T Transcatheter Tricuspid Valve Repair System and Medical therapy in people with Tricuspid Regurgitation, run by Hangzhou Valgen Medtech Co., Ltd at 2 sites in China.
Trial summary
The primary objective of this trial is to demonstrate the safety and effectiveness of the DragonFly-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. 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 and Medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 2 sitesChina
- Study dates
- 3 Sep 2024to 15 Aug 2032
- 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
- Age ≥ 18 years
- In the judgment of the local cardiac team, the patient has been adequately treated according to applicable standards (including medical management)and has been stable for at least 30 days.
- Despite the drug optimization treatment according to the above method, patients still have symptoms of TR;
- Determined by the local cardiac team to be at intermediate or higher risk for tricuspid valve surgery
- New York Heart Association (NYHA) Cardiac function Class II-IVa;
- 5. The patient is suitable for transcatheter tricuspid valve repair, suitable for the use of this study instrument, and the femoral vein access is feasible and can accommodate catheter; 6. 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, 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.
- Other serious heart valvular diseases requiring intervention or planning to intervention in the next 12 months; Note: If mitral and tricuspid valve lesions are combined, mitral valve surgery can be performed first, and re-evaluation can be performed 60 days after surgery.
Show all 11Show fewer
- Tricuspid stenosis evaluated by ECL and/or cross-tricuspid differential pressure ≥ 5 mmHg;
- Previous tricuspid valve surgery or transcatheter therapy;
- Echocardiography suggested intracardiac thrombus, tumor or mass, or femoral vein and inferior vena cava implants or thrombus;
- TTE and TEE are unable to evaluate tricuspid valve anatomy; Participated in any drug and/or medical device clinical trials within 1 month prior to the trial; ……
- 28. The researchers do not consider it appropriate to be enrolled in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Chen mao, Phd, 18980602046, hmaochen@vip.sina.com
- 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: A Prospective, Multicenter, Parallel, Randomized Controlled Study to Evaluate the Safety and Effectiveness of the DragonFly-T Transcatheter Tricuspid Valve Clip System in the Treatment of Tricuspid Regurgitation
The primary objective of this trial is to demonstrate the safety and effectiveness of the DragonFly-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (DragonFly-T system) to Control (Medical Therapy).
Read the detailed description
A Prospective, Multicenter, Parallel, Randomized Controlled Study to Evaluate the Safety and Efficacy of the DragonFly-T Transcatheter Tricuspid Valve Clip System in the Treatment of Tricuspid Regurgitation. After signing the informed consent form, participants in the experimental group will be treated with the Dejin Medical DragonFly-T Transcatheter Tricuspid Valve Clip System and continue receiving medical therapy as determined by the investigator. Participants in the control group will continue to receive medical therapy as determined by the investigator. Control group participants are allowed to cross over to the experimental group after completing the 12-month follow-up. All participants will undergo clinical follow-up before discharge (not applicable to control group participants), at 30 days post-treatment, 6 months post-treatment, 12 months post-treatment, and annually at 2, 3, 4, and 5 years..
The primary endpoint is the hierarchical composite endpoint formed by all-cause mortality or tricuspid valve reintervention, heart failure hospitalization, and KCCQ improvement at 12 months post-treatment.
To evaluate the safety and effectiveness of the Valgen Medtech DragonFly-T Transcatheter Tricuspid Valve Repair System in the treatment of patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery.
- Conditions
- Tricuspid Regurgitation
- Being tested
- DragonFly-T Transcatheter Tricuspid Valve Repair System, Medical therapy
- 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.
Medical therapyDrug
Subjects will continue to be managed on medical therapy, per physician discretion
| Study group | Role | What they receive |
|---|---|---|
| Randomized - Device Group | 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. and will continue to be managed on medical therapy, per physician discretion Receives: Device: DragonFly-T Transcatheter Tricuspid Valve Repair System |
| Randomized - Control Group | Active comparator | Subjects will continue to be managed on medical therapy, per physician discretion Receives: Drug: Medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical Composite of All-cause Death or Tricuspid Valve Intervention, Heart Failure Hospitalizations, and KCCQ Improvement
Measured: 12 months
Secondary outcomes (6)
Tricuspid regurgitation severity
Percentage of patients with tricuspid regurgitation of 2+ or less.
Measured: 30 days, 6 months, and 12 months
Change in 6 minutes walk test distance
Improvement in 6 Minute Walk Test distance
Measured: 30 days, 6 months, and 12 months
Quality of life improvement
Improvement in quality of life (QoL) , as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Measured: 30 days, 6 months, and 12 months
Acute procedural success
Measured: Immediately after procedure, Discharge: The day after the patient's exit from the cardiac catheterization laboratory
Acute device success
Measured: Immediately after procedure
Incidence of major adverse events (MAEs)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start3 Sep 2024
- Primary completion15 Aug 2028 (estimated)
- Study completion15 Aug 2032 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 236 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, PH.D, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556460
- Sponsor's protocol ID
- DF-VL-03
- Status last verified
- Jun 2026
- First submitted
- 23 Sep 2022
- Last updated
- 12 Jun 2026
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Parallel, Randomized Controlled Study to Evaluate the Safety and Effectiveness of the DragonFly-T Transcatheter Tricuspid Valve Clip System in the Treatment of Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT05556460
- Acronym / sponsor ID
- DF-VL-03
- Conditions
- Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Hangzhou Valgen Medtech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 15 Aug 2032 (estimated)
- First posted
- 27 Sep 2022 (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.
The primary objective of this trial is to demonstrate the safety and effectiveness of the DragonFly-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (DragonFly-T system) to Control (Medical Therapy).
Detailed description
A Prospective, Multicenter, Parallel, Randomized Controlled Study to Evaluate the Safety and Efficacy of the DragonFly-T Transcatheter Tricuspid Valve Clip System in the Treatment of Tricuspid Regurgitation. After signing the informed consent form, participants in the experimental group will be treated with the Dejin Medical DragonFly-T Transcatheter Tricuspid Valve Clip System and continue receiving medical therapy as determined by the investigator. Participants in the control group will continue to receive medical therapy as determined by the investigator. Control group participants are allowed to cross over to the experimental group after completing the 12-month follow-up. All participants will undergo clinical follow-up before discharge (not applicable to control group participants), at 30 days post-treatment, 6 months post-treatment, 12 months post-treatment, and annually at 2, 3, 4, and 5 years..
The primary endpoint is the hierarchical composite endpoint formed by all-cause mortality or tricuspid valve reintervention, heart failure hospitalization, and KCCQ improvement at 12 months post-treatment.
To evaluate the safety and effectiveness of the Valgen Medtech DragonFly-T Transcatheter Tricuspid Valve Repair System in the treatment of patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized - Device Group | 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. and will continue to be managed on medical therapy, per physician discretion |
| Randomized - Control Group | Active comparator | Drug: Medical therapySubjects will continue to be managed on medical therapy, per physician discretion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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)and has been stable for at least 30 days.
- Despite the drug optimization treatment according to the above method, patients still have symptoms of TR;
- Determined by the local cardiac team to be at intermediate or higher risk for tricuspid valve surgery
- New York Heart Association (NYHA) Cardiac function Class II-IVa;
Key exclusion criteria (11 listed)
- Tricuspid valve leaflet anatomy, which may preclude clip implantation, proper clip positioning on the leaflets, including but not limited to the following:
- Other serious heart valvular diseases requiring intervention or planning to intervention in the next 12 months; Note: If mitral and tricuspid valve lesions are combined, mitral valve surgery can be performed first, and re-evaluation can be performed 60 days after surgery.
- Tricuspid stenosis evaluated by ECL and/or cross-tricuspid differential pressure ≥ 5 mmHg;
- Previous tricuspid valve surgery or transcatheter therapy;
- Echocardiography suggested intracardiac thrombus, tumor or mass, or femoral vein and inferior vena cava implants or thrombus;
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 | Randomized - Device Group |
| Medical therapySubjects will continue to be managed on medical therapy, per physician discretion | Drug | Randomized - Control Group |
Primary outcome
Hierarchical Composite of All-cause Death or Tricuspid Valve Intervention, Heart Failure Hospitalizations, and KCCQ Improvement
Time frame: 12 months
6 secondary outcomes
Tricuspid regurgitation severity
Time frame: 30 days, 6 months, and 12 months
Change in 6 minutes walk test distance
Time frame: 30 days, 6 months, and 12 months
Quality of life improvement
Time frame: 30 days, 6 months, and 12 months
Acute procedural success
Time frame: Immediately after procedure, Discharge: The day after the patient's exit from the cardiac catheterization laboratory
Acute device success
Time frame: Immediately after procedure
Incidence of major adverse events (MAEs)
Time frame: 30 days
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 12 Jun 2026.
- 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.
Jian'an Wang, MD, PH.D principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
2 sites 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 and Medical therapy in people with Tricuspid Regurgitation, run by Hangzhou Valgen Medtech Co., Ltd at 2 sites 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 6 inclusion and 11 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Bo Liu (+8613001980902, bo.liu@valgenmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical Composite of All-cause Death or Tricuspid Valve Intervention, Heart Failure Hospitalizations, and KCCQ Improvement (time frame: 12 months). 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 12 Jun 2026.