Clinical trial NCT05671640: Feasibility Study of the DragonFly-T System for Severe Tricuspid Regurgitation
Official title: Feasibility Study of the DragonFly-T Transcatheter Tricuspid Valve Repair System for the Treatment of Tricuspid Regurgitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tricuspid Regurgitation
Keywords: Tricuspid Regurgitation
Lead sponsor: Hangzhou Valgen Medtech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-01-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of major adverse events (MAEs)
timeFrame: 30 days
Secondary outcomes:
measure: Acute procedural success
timeFrame: Immediately after procedure
measure: Acute device success
timeFrame: Immediately after procedure
measure: Incidence of all-cause mortality and/or heart failure rehospitalization
timeFrame: 12 months
measure: Tricuspid regurgitation severity
timeFrame: 30 days, 6 months, 12 months
measure: Tricuspid regurgitation severity change
timeFrame: 30 days, 6 months, 12 months
measure: Change in 6 Minutes Walk Test
timeFrame: 30 days, 6 months, 12 months
measure: Change in NYHA class
timeFrame: 30 days, 6 months, 12 months
measure: Quality of life improvement
timeFrame: 30 days, 6 months, 12 months
measure: Change in edema grading
timeFrame: 30 days, 6 months, 12 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jian'an Wang, MD,Phd
role: PRINCIPAL_INVESTIGATOR
References: