Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation

A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Safety and Effectiveness of DragonFly-T Transcatheter Tricuspid Valve Repair System for the Treatment of Tricuspid Regurgitation Subjects

To confirm the effectiveness and safety of the DragonFly-T transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation (TR) (TR grade ≥ 3+) who remained clinically symptomatic after guideline-directed medical treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Device: DragonFly-T Transcatheter Tricuspid Valve Repair System

Detailed Description

This study is a prospective, multicenter, objective performance criteria design. Patients are severe 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 primary outcome is defined as a composite measure including all-cause mortality and recurrent heart failure hospitalization 12 months after the procedure.

The secondary outcomes include acute procedural success, acute device success, 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 distance, New York Heart Association (NYHA) class, quality of life change as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score and edema scale grading.

To evaluate the safety and effectiveness of the Valgen Medtech DragonFly-T Transcatheter Tricuspid Valve Repair System in the treatment of patients with severe TR (≥ 3+) who remained clinically symptomatic after guideline-directed medical treatment,and to evaluate the product performance.

• Study Type: Interventional
• Enrollment (Anticipated): 151
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shuangjie Li; Phone Number: +8617756106609; Email: shuangjie.li@valgenmed.com
• Study Contact Backup: Name: Kangmu Ma; Phone Number: +8613341773508; Email: makangmu@valgenmed.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;
4. New York Heart Association (NYHA) Cardiac function Class II-IVa without severe cirrhosis (Child's grade C);
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 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, 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. 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.
3. Tricuspid stenosis evaluated by ECL and/or cross-tricuspid differential pressure ≥ 5 mmHg;
4. Previous tricuspid valve surgery or transcatheter therapy;
5. Echocardiography suggested intracardiac thrombus, tumor or mass, or femoral vein and inferior vena cava implants or thrombus;
6. TTE and TEE are unable to evaluate tricuspid valve anatomy;
7. Left ventricular ejection fraction (LVEF) ≤ 35%;
8. Refractory heart failure requiring intervention (e.g., left ventricular assist device, heart transplantation) (ACC/AHA Stage D heart failure);
9. Pulmonary artery systolic pressure >60 mmHg, or irreversible pre-capillary pulmonary hypertension (iPASP>70mmHg, and PVR>5WU with/without vasodilator challenge), or PCWP is greater than 18mmHg, with a setting-up of a systolic blood pressure greater than 90mmHg) (RHC is required for every patient)
10. Severe and uncontrolled hypertension: systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 110mmHg;
11. Active endocarditis, active rheumatic heart disease, or rheumatic heart valvular disease leading to tricuspid valve leaf lesions (poor valve leaf compliance, perforation, etc.);
12. After ICD surgery, or the pacemaker lead caused TR;
13. Cardiac resynchronization therapy for less than 3 months
14. Had myocardial infarction or unstable angina within 4 weeks; Untreated severe coronary artery stenosis requiring revascularization;
15. Percutaneous coronary intervention was performed within 30 days before surgery, except for coronary angiography;
16. Hemodynamic instability, defined as systolic blood pressure < 90mmHg, with or without cardiogenic shock, or requiring intra-aortic balloon counterpulsation or other hemodynamic support devices;
17. Cerebrovascular accident occurred within 90 days;
18. (estimated) glomerular filtration rate (eGFR) < 25 ml/min or dialysis patients；
19. Bleeding diseases or coagulation disorders, or antithrombotic drug therapy contraindications;
20. Acute peptic ulcer or gastrointestinal bleeding within 3 months before surgery;
21. For active infection, antibiotics should be treated at the same time (for temporary disease, antibiotics should be stopped at least 14 days before patients can be included in the group);
22. Severe cirrhosis (Child's grade C);
23. Severe chronic obstructive pulmonary disease requiring continuous oxygen inhalation;
24. Allergy to the device material;
25. Life expectancy of fewer than 12 months;
26. Women who are pregnant, breastfeeding, or planning to become pregnant;
27. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DragonFly-T Tricuspid Valve Repair System; 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.	Device: DragonFly-T Transcatheter Tricuspid Valve Repair System; To conduct edge-to-edge repair with DragonFly-T System under the guidance of transesophageal echocardiography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with composite measures- All-cause death and recurrent HF hospitalizations.	A composite of all-cause death or recurrent heart failure (HF) hospitalizations.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tricuspid regurgitation severity	Percentage of patients with tricuspid regurgitation of 2+ or less.	30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
Tricuspid regurgitation severity change	Percentage of patients with tricuspid regurgitation reduced by at least one grade.	30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
Change in 6 minutes walk test distance	Improvement in 6 Minute Walk Test distance	30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
Change in NYHA Class	Improvement in New York Heart Association (NYHA) Function Class	30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
Quality of life improvement	Improvement in quality of life (QoL) , as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).	30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
Change in Edema Grading	Improvement in Grading of Edeme	30 days, 6 months, 12 months, and 2, 3, 4, and 5 years
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, Discharge: The day after the patient's exit from the cardiac catheterization laboratory
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse events (MAEs)	MAE is defined as a combined clinical endpoint of death, stroke, myocardial infarction, renal failure, and nonelective cardiovascular surgery for device or procedure-related adverse events occurring after transseptal catheterization.	30 days, 12 months, and 2, 3, 4, and 5 years

Collaborators and Investigators

• Sponsor: Hangzhou Valgen Medtech Co., Ltd
• Investigators: Principal Investigator: Jian'an Wang, MD, PH.D, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2022
• Primary Completion (Anticipated): October 15, 2024
• Study Completion (Anticipated): October 15, 2028

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: DF-VL-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No