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

NCT05556460 | Recruiting

• 1 other identifier: DF-VL-03
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 2

Brief 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. This randomized controlled trial will compare the investigational device (DragonFly-T system) to Control (Medical Therapy).

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

• Hierarchical Composite of All-cause Death or Tricuspid Valve Intervention, Heart Failure Hospitalizations, and KCCQ Improvement

  12 months

Secondary Outcomes (6)

• Tricuspid regurgitation severity

  30 days, 6 months, and 12 months

• Change in 6 minutes walk test distance

  30 days, 6 months, and 12 months

• Quality of life improvement

  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

Study Arms (2)

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

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

Drug: Medical therapy

Interventions

DragonFly-T Transcatheter Tricuspid Valve Repair System DEVICE

To conduct edge-to-edge repair with DragonFly-T System under the guidance of transesophageal echocardiography.

Randomized - Device Group

Medical therapy DRUG

Subjects will continue to be managed on medical therapy, per physician discretion

Randomized - Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• \. 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.

You may not qualify if:

• 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.
• 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; ……
• \. The researchers do not consider it appropriate to be enrolled in the study.

Sponsors & Collaborators

• Hangzhou Valgen Medtech Co., Ltd: lead

Study Sites (2)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jian'an Wang, MD, PH.D

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Liu

CONTACT

+8613001980902; bo.liu@valgenmed.com

Shuangjie Li

CONTACT

+8617756106609; shuangjie.li@valgenmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 27, 2022
• Study Start: August 15, 2024
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)