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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство DragonFly-T Transcatheter Tricuspid Valve Repair System
  To conduct edge-to-edge repair with DragonFly-T System under the guidance of transesophageal echocardiography.
• Препарат Medical therapy
  Subjects will continue to be managed on medical therapy, per physician discretion

Первичные конечные точки

• Hierarchical Composite of All-cause Death or Tricuspid Valve Intervention, Heart Failure Hospitalizations, and KCCQ Improvement [Срок оценки: 12 months]

Вторичные конечные точки (6)

• Tricuspid regurgitation severity [Срок оценки: 30 days, 6 months, and 12 months]
• Change in 6 minutes walk test distance [Срок оценки: 30 days, 6 months, and 12 months]
• Quality of life improvement [Срок оценки: 30 days, 6 months, and 12 months]
• Acute procedural success [Срок оценки: Immediately after procedure, Discharge: The day after the patient's exit from the cardiac catheterization laboratory]
• Acute device success [Срок оценки: Immediately after procedure]
• Incidence of major adverse events (MAEs) [Срок оценки: 30 days]

Критерии участия

Критерии включения

• 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;

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.

Критерии исключения

• 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; ……

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• West China Hospital of Sichuan University — Чэнду
• The Second Affiliated Hospital Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT05556460 · DF-VL-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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