Feasibility Study of the DragonFly-T System for Severe Tricuspid Regurgitation

Tricuspid Regurgitation Clinical Trial

Official title:

Feasibility Study of the DragonFly-T Transcatheter Tricuspid Valve Repair System for the Treatment of Tricuspid Regurgitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05671640
• Other study ID #: DragonFly-T-2
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: January 10, 2024

Study information

• Verified date: January 2023
• Source: Hangzhou Valgen Medtech Co., Ltd
• Contact: Kangmu Ma
• Phone: +8613341773508
• Email: makangmu[@]valgenmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 10, 2024
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. In the judgment of the local cardiac team, the patient has been adequately treated

according to applicable standards (including medical management), including:

1. Optimal pharmacological therapy for TR (e.g. diuretics);

2. Drug and/or interventional treatment of mitral regurgitation, atrial fibrillation, coronary artery disease, and heart failure;

3. The Eligibility Committee confirms that the patient has received adequate medical treatment.

3. Despite the drug optimization treatment according to the above method, patients still have symptoms of TR (TR grade=3+).

4. 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 the study device, and the femoral vein access is feasible and can accommodate a 24F catheter.

6. Patient must provide written informed consent before any steps related to the study.

Exclusion Criteria:

1. Tricuspid valve leaflet anatomy, which may preclude clip implantation or proper clip

positioning on the leaflets, including but not limited to the following:

1. Evidence of calcification in the grasping area;

2. Presence of a severe coaptation defect of the tricuspid leaflets;

3. Severe leaflet defect(s) and cleft preventing proper device placement determined by ECL;

4. Epstein anomaly.

2. Previous tricuspid valve surgery or transcatheter therapy.

3. Echocardiography suggested intracardiac thrombus, tumor, or mass.

4. Transthoracic Echocardiogram and Transesophageal Echocardiography are unable to evaluate tricuspid valve anatomy.

5. Refractory heart failure requiring intervention (e.g., left ventricular assist device, heart transplantation) (ACC/AHA Stage D heart failure).

6. Severe and uncontrolled hypertension: systolic blood pressure = 180mmHg and/or diastolic blood pressure = 110mmHg.

7. Active endocarditis, active rheumatic heart disease, or rheumatic heart valvular disease leading to tricuspid valve leaf lesions (poor valve leaf compliance, perforation, etc.).

8. Had myocardial infarction or unstable angina within 4 weeks; Untreated severe coronary artery stenosis requiring revascularization.

9. Percutaneous coronary intervention was performed within 30 days before surgery, except for coronary angiography.

10. Hemodynamic instability, defined as systolic blood pressure < 90mmHg, with or without cardiogenic shock, or requiring intra-aortic balloon counterpulsation or other hemodynamic support devices.

11. Bleeding diseases or coagulation disorders, or antithrombotic drug therapy contraindications.

12. Acute peptic ulcer or gastrointestinal bleeding within 3 months before surgery.

13. Severe cirrhosis (Child's grade C).

14. Allergy to the device material.

15. Life expectancy of fewer than 12 months.

16. Women who are pregnant, breastfeeding, or planning to become pregnant.

17. Participated in any drug and/or medical device clinical trials within 1 month prior to the trial.

18. The researchers do not consider it appropriate to be enrolled in the study.

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• DragonFly-T Transcatheter Tricuspid Valve Repair System
To conduct edge-to-edge repair with DragonFly-T System under the guidance of transesophageal echocardiography.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Valgen Medtech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Secondary	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	Immediately after procedure
Secondary	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	Immediately after procedure
Secondary	Incidence of all-cause mortality and/or heart failure rehospitalization	Incidence of all-cause mortality and/or heart failure rehospitalization	12 months
Secondary	Tricuspid regurgitation severity	Percentage of patients with tricuspid regurgitation of 2+ or less	30 days, 6 months, 12 months
Secondary	Tricuspid regurgitation severity change	Percentage of patients with tricuspid regurgitation reduced by at least one grade	30 days, 6 months, 12 months
Secondary	Change in 6 Minutes Walk Test	Improvement in 6 Minute Walk Test	30 days, 6 months, 12 months
Secondary	Change in NYHA class	Improvement in New York Heart Association (NYHA) Function Class	30 days, 6 months, 12 months
Secondary	Quality of life improvement	Improvement in quality of life (QoL) , as measured by the Kansas City Cardiomyopathy Questionnaire	30 days, 6 months, 12 months
Secondary	Change in edema grading	Improvement in grading of edema,1-4 grade scale,higher scores mean worse outcome	30 days, 6 months, 12 months