Tricuspid RegurgitationNCT04921605
Feasibility Study of Dragonfly System for Severe Tricuspid Regurgitation
A study testing DragonFly transcatheter mitral valve clamping system in people with Tricuspid Regurgitation, run by Hangzhou Valgen Medtech Co., Ltd at 1 site in China.
Trial summary
The study is designed to assess the feasibility of the DragonFly transcatheter mitral valve clamping system for the treatment of symptomatic severe tricuspid regurgitation. 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 transcatheter mitral valve clamping 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
- 15 Dec 2020to 15 Jun 2023
- 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.
- Subject is medically treated, remains symptomatic and has severe tricuspid regurgitation confirmed by echocardiogram.
- New York Heart Function Class (NYHA) II-IVa, or hospitalization for heart failure due to one or more episodes in the past 12 months.
- Patient eligible for transcatheter tricuspid repair as well as suitable for use of the study device.
- Subject had an expected moderate or greater surgical risk confirmed by the cardiac surgeon, or the subject as not suitable for surgical thoracotomy confirmed by local doctor.
- Life expectancy ≥ 12 months.
- Subjects have been informed of the nature of the study, understand the purpose of the clinical trial, voluntarily participate, agree to its provisions, and have provided written informed consent approved by the Ethics Committee.
Who cannot join
- Tricuspid valve anatomy not suitable for device positioning or implantation as assessed by the clinical team, including but not limited to the following: a) calcification in the leaflet capture area; b) tricuspid valve perforation defect>2 cm; c) severe tricuspid valve leaflet perforation, fissure and other lesions that preclude device implantation; d) Ebstein malformation.
- Presence of other serious valvular heart disease requiring intervention such as combined severe aortic stenosis or regurgitation, severe mitral regurgitation. Note: If combined with mitral and tricuspid valve lesions, mitral valve surgery can be selected first, and trial evaluation can be conducted after waiting for 60 days.
- Tricuspid stenosis, defined as tricuspid valve orifice area ≤ 1.0 cm2 and/or trans-tricuspid pressure difference ≥ 5 mmHg.
- After tricuspid surgery or tricuspid transcatheter treatment.
- Echocardiogram suggesting an intracardiac thrombus, vegetation, or mass; implant or thrombus in the femoral vein or inferior vena cava.
- Left ventricular ejection fraction (LVEF) ≤ 20%.
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- Refractory heart failure requiring advanced intervention (eg, left ventricular assist device, heart transplant) (ACC/AHA stage D heart failure).
- Pulmonary artery systolic pressure>70 mmHg, or irreversible pre-capillary pulmonary hypertension (measured by right heart catheter).
- Severe and uncontrolled hypertension: systolic blood pressure (SBP) ≥ 180 mmHg and diastolic blood pressure (DBP) ≥ 110 mmHg.
- Active endocarditis, active rheumatic heart disease, or rheumatic valvular heart disease leading to tricuspid valve leaflet lesions (poor leaflet compliance, perforation, etc.).
- After a pacemaker or ICD implantation.
- Myocardial infarction or unstable angina within 4 weeks; untreated severe coronary stenosis requiring revascularization.
- Percutaneous coronary intervention was performed within 30 days before surgery.
- Hemodynamic instability, defined as systolic blood pressure<90mmHg with or without cardiogenic shock or requiring intra-aortic balloon counterpulsation or other hemodynamic support device.
- Cerebrovascular accident (CVA) within the previous 90 days.
- Renal failure, currently requiring dialysis.
- Bleeding disorder or hypercoagulability.
- Acute peptic ulcer or gastrointestinal bleeding within 3 months prior to surgery.
- Concurrent treatment contraindication or allergic reaction to dual antiplatelet and anticoagulant drugs. Note: Antiplatelet drugs alone or anticoagulant drugs are contraindicated and not used as exclusion criteria.
- Active infection, currently requiring antibiotic therapy.
- Severe chronic obstructive pulmonary disease requiring continuous oxygen inhalation.
- Known hypersensitivity to device materials.
- Life expectancy less than 12 months.
- Pregnant and lactating women, women who are ready to conceive.
- Patients who have participated in any drug and/or medical device clinical trial within 1 month prior to this trial.
- Subjects deemed unsuitable for the study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: A Clinical Study of Management of Severe Tricuspid Regurgitation With Transcatheter Mitral Valve Clamping System
The study is designed to assess the feasibility of the DragonFly transcatheter mitral valve clamping system for the treatment of symptomatic severe tricuspid regurgitation.
Read the detailed description
This study is a prospective, single-center design. Patients are clinically symptomatic patients with severe tricuspid regurgitation despite medical therapy with an expected moderate or greater surgical risk and prohibited to thoracotomy. After signing an informed consent form, subjects are enrolled and treated with the DragonFly Transcatheter Mitral Valve Repair System. All subjects receive clinical follow-up immediately after the procedure, before discharge, and 30 days, 6 months, 12 months and 24 months after the procedure.
Incidence of MAEs at 30 days and immediate procedural success is used as the primary endpoint. The MAEs include device- or procedure-related death, myocardial infarction, stroke, renal failure, and nonelective cardiovascular surgery associated with adverse events. The immediate procedural success is defined as successful implantation of a tricuspid valve-clamp device with at least a one-grade reduction in severity of tricuspid regurgitation at discharge (30-day echocardiography if discharge records were not available or were uninterpretable). Subjects who died or underwent tricuspid valve surgery prior to discharge were defined as immediate procedure failure.
The secondary endpoints include all-cause mortality, cardiovascular-related mortality, the incidence of serious adverse events, heart failure rehospitalization, changes of NYHA classification, reduction of tricuspid regurgitation severity, the proportion of reoperations, changes of quality of life as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) score.
The study comprises two main objectives, firstly, to assess the safety and effectiveness of the DragonFly transcatheter mitral valve clamping system for the treatment of symptomatic severe tricuspid regurgitation despite medical therapy with an expected moderate or greater surgical risk and prohibited to thoracotomy. Secondly, to evaluate the feasibility and performance of the device and to familiarize clinicians with the device and procedure.
- Conditions
- Tricuspid Regurgitation
- Being tested
- DragonFly transcatheter mitral valve clamping system
- 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 transcatheter mitral valve clamping systemDevice
To conduct edge-to-edge repair with Dragonfly System under the guidance of transesophageal echocardiography.
| Study group | Role | What they receive |
|---|---|---|
| Tricuspid regurgitation | Experimental | Subjects received the Dragonfly system for the treatment of tricuspid regurgitation. Receives: Device: DragonFly transcatheter mitral valve clamping system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse events
Major adverse events included device- or procedure-related death, myocardial infarction, stroke, renal failure, and nonelective cardiovascular surgery associated with adverse events.
Measured: 30days
Immediate procedural success
Defined as successful implantation of a tricuspid valve-clamp device with at least a one-grade reduction in severity of tricuspid regurgitation at discharge (30-day echocardiography if discharge records were not available or were uninterpretable). Subjects who died or underwent tricuspid valve surgery prior to discharge were defined as immediate procedure failure.
Measured: up to 30 days
Secondary outcomes (8)
All-cause mortality
All-cause mortality included cardiac, non-cardiac, and unexplained death
Measured: 12, 24 months
Cardiovascular-related mortality
Incidence of cardiovascular-related mortality
Measured: 12, 24 months
Serious adverse events
Incidence of serious adverse events
Measured: 12, 24 months
Heart failure rehospitalization
Incidence of heart failure rehospitalization
Measured: 12, 24 months
NYHA classification
Changes of NYHA classification from baseline
Measured: 30 days, 6 months, 12 months and 24 months
Tricuspid regurgitation reduction
Proportion of postoperative reduction in severity of tricuspid regurgitation
Measured: 30 days, 6 months, 12 months and 24 months
Reoperations of Tricuspid regurgitation
Proportion of reoperations for tricuspid regurgitation after procedure
Measured: 30 days, 6 months, 12 months and 24 months
Quality of life assessment
Changes in quality of life as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline
Measured: 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start15 Dec 2020
- Primary completion15 Sep 2022 (estimated)
- Study completion15 Jun 2023 (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
- Jianan Wang, MD, PH.D, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921605
- Sponsor's protocol ID
- DragonFly-T-I
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 29 Mar 2022
- 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 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Management of Severe Tricuspid Regurgitation With Transcatheter Mitral Valve Clamping System
- ClinicalTrials.gov ID
- NCT04921605
- Acronym / sponsor ID
- DragonFly-T-I
- Conditions
- 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
- 15 Dec 2020 (actual)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 10 Jun 2021 (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 study is designed to assess the feasibility of the DragonFly transcatheter mitral valve clamping system for the treatment of symptomatic severe tricuspid regurgitation.
Detailed description
This study is a prospective, single-center design. Patients are clinically symptomatic patients with severe tricuspid regurgitation despite medical therapy with an expected moderate or greater surgical risk and prohibited to thoracotomy. After signing an informed consent form, subjects are enrolled and treated with the DragonFly Transcatheter Mitral Valve Repair System. All subjects receive clinical follow-up immediately after the procedure, before discharge, and 30 days, 6 months, 12 months and 24 months after the procedure.
Incidence of MAEs at 30 days and immediate procedural success is used as the primary endpoint. The MAEs include device- or procedure-related death, myocardial infarction, stroke, renal failure, and nonelective cardiovascular surgery associated with adverse events. The immediate procedural success is defined as successful implantation of a tricuspid valve-clamp device with at least a one-grade reduction in severity of tricuspid regurgitation at discharge (30-day echocardiography if discharge records were not available or were uninterpretable). Subjects who died or underwent tricuspid valve surgery prior to discharge were defined as immediate procedure failure.
The secondary endpoints include all-cause mortality, cardiovascular-related mortality, the incidence of serious adverse events, heart failure rehospitalization, changes of NYHA classification, reduction of tricuspid regurgitation severity, the proportion of reoperations, changes of quality of life as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) score.
The study comprises two main objectives, firstly, to assess the safety and effectiveness of the DragonFly transcatheter mitral valve clamping system for the treatment of symptomatic severe tricuspid regurgitation despite medical therapy with an expected moderate or greater surgical risk and prohibited to thoracotomy. Secondly, to evaluate the feasibility and performance of the device and to familiarize clinicians with the device and procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tricuspid regurgitation | Experimental | Device: DragonFly transcatheter mitral valve clamping systemSubjects received the Dragonfly system for the treatment of tricuspid regurgitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years.
- Subject is medically treated, remains symptomatic and has severe tricuspid regurgitation confirmed by echocardiogram.
- New York Heart Function Class (NYHA) II-IVa, or hospitalization for heart failure due to one or more episodes in the past 12 months.
- Patient eligible for transcatheter tricuspid repair as well as suitable for use of the study device.
- Subject had an expected moderate or greater surgical risk confirmed by the cardiac surgeon, or the subject as not suitable for surgical thoracotomy confirmed by local doctor.
Key exclusion criteria (26 listed)
- Tricuspid valve anatomy not suitable for device positioning or implantation as assessed by the clinical team, including but not limited to the following: a) calcification in the leaflet capture area; b) tricuspid valve perforation defect>2 cm; c) severe tricuspid valve leaflet perforation, fissure and other lesions that preclude device implantation; d) Ebstein malformation.
- Presence of other serious valvular heart disease requiring intervention such as combined severe aortic stenosis or regurgitation, severe mitral regurgitation. Note: If combined with mitral and tricuspid valve lesions, mitral valve surgery can be selected first, and trial evaluation can be conducted after waiting for 60 days.
- Tricuspid stenosis, defined as tricuspid valve orifice area ≤ 1.0 cm2 and/or trans-tricuspid pressure difference ≥ 5 mmHg.
- After tricuspid surgery or tricuspid transcatheter treatment.
- Echocardiogram suggesting an intracardiac thrombus, vegetation, or mass; implant or thrombus in the femoral vein or inferior vena cava.
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 transcatheter mitral valve clamping systemTo conduct edge-to-edge repair with Dragonfly System under the guidance of transesophageal echocardiography. | Device | Tricuspid regurgitation |
Primary outcome
Major adverse events
Time frame: 30days
Major adverse events included device- or procedure-related death, myocardial infarction, stroke, renal failure, and nonelective cardiovascular surgery associated with adverse events.
Immediate procedural success
Time frame: up to 30 days
Defined as successful implantation of a tricuspid valve-clamp device with at least a one-grade reduction in severity of tricuspid regurgitation at discharge (30-day echocardiography if discharge records were not available or were uninterpretable). Subjects who died or underwent tricuspid valve surgery prior to discharge were defined as immediate procedure failure.
8 secondary outcomes
All-cause mortality
Time frame: 12, 24 months
Cardiovascular-related mortality
Time frame: 12, 24 months
Serious adverse events
Time frame: 12, 24 months
Heart failure rehospitalization
Time frame: 12, 24 months
NYHA classification
Time frame: 30 days, 6 months, 12 months and 24 months
Tricuspid regurgitation reduction
Time frame: 30 days, 6 months, 12 months and 24 months
Reoperations of Tricuspid regurgitation
Time frame: 30 days, 6 months, 12 months and 24 months
Quality of life assessment
Time frame: 12, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- 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.
Jianan Wang, MD, PH.D 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 transcatheter mitral valve clamping 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 7 inclusion and 26 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 29 Mar 2022. 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?
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?
Major adverse events (time frame: 30days). The study lists 2 primary outcomes in all. 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 29 Mar 2022.