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

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).

Study Overview

• Status: Recruiting
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Device: DragonFly-T Transcatheter Tricuspid Valve Repair System; Drug: 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 Type: Interventional
• Enrollment (Estimated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shuangjie Li; Phone Number: +8617756106609; Email: shuangjie.li@valgenmed.com
• Study Contact Backup: Name: Bo Liu; Phone Number: +8613001980902; Email: bo.liu@valgenmed.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital of Sichuan University
      • Contact: Chen mao, Phd; Phone Number: 18980602046; Email: hmaochen@vip.sina.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Jian'an Wang, MD,Phd; Phone Number: +8613805786328; Email: wja@zju.edu.cn

Participation Criteria

Eligibility Criteria

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

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)and has been stable for at least 30 days.
3. Despite the drug optimization treatment according to the above method, patients still have symptoms of TR;
4. Determined by the local cardiac team to be at intermediate or higher risk for tricuspid valve surgery
5. 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.

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; 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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Randomized - Control Group; Subjects will continue to be managed on medical therapy, per physician discretion	Drug: Medical therapy; Subjects will continue to be managed on medical therapy, per physician discretion
Experimental: Randomized - Device Group; 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	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	Time Frame
Hierarchical Composite of All-cause Death or Tricuspid Valve Intervention, Heart Failure Hospitalizations, and KCCQ Improvement	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, and 12 months
Change in 6 minutes walk test distance	Improvement in 6 Minute Walk Test distance	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).	30 days, 6 months, and 12 months
Acute procedural success		Immediately after procedure, Discharge: The day after the patient's exit from the cardiac catheterization laboratory
Acute device success		Immediately after procedure
Incidence of major adverse events (MAEs)		30 days

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 (Estimated): August 15, 2024
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): December 15, 2027

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): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

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