Dragonfly-M Transcatheter Mitral Valve Repair System Early Feasibility Study
Phase: NA
Conditions: Mitral Regurgitation
Sponsor: Hangzhou Valgen Medtech Co., Ltd

Transcatheter Mitral Valve Repair System  
Early Feasibility Study Protocol 
 
 
 
 
 
Device Name:  
Dragonfly-MTM Transcatheter Mitral Valve Repair System 
Version: V1.0 
Date: June 8th, 2020

Protocol Synopsis 
Protocol name: Dragonfly-MTM Transcatheter Mitral Valve Repair System – Early Feasibility 
Study Protocol 
Objectives: To evaluate the safety and device performance of the Dragonfly-MTM transcatheter 
mitral valve repair system for the treatment of moderate-to-severe or severe mitral regurgitation in 
high or prohibitive surgical risk subjects. This trial is designed to study the reliability and operator 
performance of the Dragonfly-MTM transcatheter mitral valve repair system in an early feasibility 
study. 
Trial products: Dragonfly-MTM Transcatheter Mitral Valve Repair System 
Indications: Moderate-to-severe (3+) and severe (4+) mitral regurgitation in high or prohibitive 
surgical risk subjects. 
Trial design: The subjects with moderate-to-severe (3+) and severe (4+) mitral valve regurgitation 
(MR) at high or prohibitive surgical risk will be evaluated by the study sites, and study eligibility 
confirmed by the echocardiographic core laboratory and eligibility committee. Those qualifying 
will then be treated with Dragonfly-MTM transcatheter mitral valve repair system after signing the 
informed consent. The follow-up will be conducted at discharge, 30 days, 6 months and 12 months 
after the operation. The primary endpoints are the incidence of major adverse events (MAE) at 30 
days, and acute procedural success. Acute procedural success is defined as placement of one or more 
Dragonfly-MTM devices on the mitral valve with reduction of MR to 2+ or less. The secondary 
endpoints include all-cause mortality, cardiovascular mortality, incidence of serious adverse event, 
cardiovascular rehospitalization, NYHA functional class, mitral valve hemodynamics, acute 
technical success rate and device success rate at 6 months. Acute technical success is defined as no 
procedural mortality, successful in access, delivery, and retrieval of the device delivery system, and 
no emergency surgery or reintervention related to the device or access procedure in the 
catheterization laboratory. Device success is defined as no procedural mortality, proper delivery and 
deployment of the device, no unplanned surgical or interventional procedures related to the device, 
no specific device-related technical failure and or complications, function improvement of MR 
without significant stenosis (MR ≤ 2+) and without associated hemolysis or thrombogenesis. 
 

Follow-up duration: Follow-up will be conducted at discharge, 30 days, 6 months and 12 months 
after operation. 
Inclusion criteria: 
1. Age ≥ 18 yrs 
2. Moderate–to-severe (3+) or severe (4+) mitral valve regurgitation on transthoracic or 
transesophageal echocardiography, and confirmed by echocardiographic core laboratory 
3. The patient is on optimal guideline directed medical therapy for heart failure and remains 
symptomatic. 
4. High or prohibitive surgical risk as defined by either Society for Thoracic Surgery Risk 
Calculator score for valve replacement ≥ 8 points; or STS score for valve repair ≥ 6 points , 
prohibitive risk as determined by the clinical judgement of the site heart team, including a 
cardiac surgeon experienced in mitral valve surgery and a cardiologist experience in mitral 
valve disease, due to the presence of one or more documented surgical risk factors. 
5.  Anatomically suitable for mitral valve repair and can be treated by Dragonfly-MTM confirmed 
by both site investigators, echocardiographic core laboratory, and the eligibility committee.  
6.  Transseptal catheterization and femoral vein access is determined to be feasible 
7.  Life expectancy ≥ 12 months 
8.  The subject or the subject’s legal representative has been informed of the nature of the trial, 
willing to accept the experimental tests and follow-ups, and has provided written informed 
consent 
Exclusion criteria: 
1. 
History of heart transplantation, prior mitral valve replacement surgery. or transcatheter mitral 
valve procedure; 
2. 
Leaflet anatomy which may preclude Dragonfly-MTM implantation and position, as judged by 
the site investigators and confirmed by the echocardiographic core laboratory and eligibility 
committee 
3. 
Evidence of calcification or significant cleft in the grasping area 
4. 
LVEF < 20% 
5. 
LVESD≥ 60mm; 
6. 
Mobile leaflet length＜10mm  

7. Mitral valve effective orifice area (EOA) < 3.5cm2 or in the opinion of site investigators and 
confirmed by the echocardiographic core laboratory and eligibility committee that mitral 
stenosis would result from implantation of the Dragonfly-MTM device. 
8. 
Echocardiographic evidence of intracardiac mass, thrombus or vegetation;  
9. 
Severe non-mitral valve disease requiring treatment . 
10. Severe pulmonary artery hypertension (sPAP＞70mmHg) 
11. Severe right ventricular dysfunction; 
12. Active endocarditis or previous mitral valve endocarditis; Active rheumatic heart disease or 
leaflets degenerated from rheumatic disease 
13. Severe untreated coronary artery stenosis requiring revascularization; or with other 
cardiovascular disease requiring surgical treatment； 
14. Extreme frailty  
15. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis and any 
other structural heart disease causing heart failure other than dilated cardiomyopathy; 
16. Renal failure requiring dialysis; 
17. Blood cachexia including granulocytopenia (WBC < 3×109/L), acute anemia (HB < 90g/L), 
thrombocytopenia (PLT < 50×109/L), severe coagulopathy, and contradictions of 
anticoagulant and antiplatelet agents; 
18. Evidence of an acute myocardial infarction in the prior 4 weeks; 
19. Evidence of a shock in the prior 90 days;  
20. Any percutaneous cardiac intervention or carotid surgery or any cardiac surgery within the 30 
days prior to randomization; 
21. Evidence of acute peptic ulcer upper or gastrointestinal hemorrhage in the prior 90 days; 
22. Severe symptomatic carotid artery stenosis over 70% confirmed by echocardiography;  
23. The subjects suffer from diseases which may lead difficulty in evaluating treatment (e.g., 
cancer, infection, severe metabolic disease, psychosis, etc.); or special cases that were 
evaluated by the heart team of local experimental center as not suitable for the surgical 
application of this clinical trial; 
24. Life expectancy ≤ 12 months;  

25. Subject participating in an investigational drug or another device study within the past 1 month; 
26. In the judgment of the investigator, subjects may not complete the trial according to poor 
compliance. 
Primary Effectiveness Endpoint:  
1) Incidence of major adverse event (MAE) at 30 days 
Major adverse event is defined as one of the following components: death, myocardial 
infarction (MI), stroke, renal failure requiring dialysis, and cardiac surgery for Dragonfly-MTM 
device failure. 
2) Acute procedural success 
The acute procedural success is defined as successful Dragonfly-MTM implantation, and 
residual MR of 2+ or less at discharge. An 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 mitral valve prior to 30 days is defined as acute procedure failure 
Secondary Effectiveness Endpoints: 
1. 
All-cause mortality (frame:6 months) 
2. 
Cardiovascular mortality (frame:6 months) 
3. 
Incidence of serious adverse event (SAE）(frame:6 months). If the adverse event meets 
any of the criteria below, it is regarded as a serious adverse event (SAE): 1) results in death; 
2) is life threatening, results in illness or injury; 3) requires inpatient hospitalization or 
prolongation of existing hospitalization; 4) results in a persistent or significant 
disability/incapacity; 5) results in a congenital anomaly/birth defect, fetal death, fetal 
distress; 6) results in medical or surgical intervention to prevent permanent impairment to 
body structure or a body function; 7) an important medical event that may not result in 
death, be life-threatening, or require hospitalization but may be considered serious when, 
based upon appropriate medical judgment, may jeopardize the patient or subject and/or 
may require intervention to prevent one of the outcomes listed in this definition. 
4. 
Incidence of cardiovascular rehospitalization (frame:6 months) 
5. 
NYHA functional class (frame:6 months) 
6. 
Mitral valve hemodynamics (frame: 6 months): include residual mitral regurgitation 
degree,  and mean mitral valve gradient. 

7. 
Technical success (frame: in the catheterization laboratory): must meet all of the following 
items: 1) no procedural mortality; and 2) successful in access, delivery, and retrieval of the 
device delivery system; and 3) no emergency surgery or reintervention related to the device 
or access procedure. 
8. 
Device success (frame: 6 months): must meet all of the following items:1) No procedural 
mortality; 2) Proper delivery and deployment of the device; 3) No unplanned surgical or 
interventional procedures related to the device; 4) No specific device-related technical 
failure or complication. 5) Improvement of MR without significant stenosis (MR ≤ 2+) 
without associated hemolysis or thrombogenesis. 
Sample size: 20 cases 
 
Clinical evaluation schedule: 
Items 
Screening/ 
Baseline 
During 
procedure 
Follow up 
discharge 1month 
6month 
12months 
Time frame 
-14d to 0d  
0 
- 
±14d 
±30d 
±45d 
Informed consent 
X 
  
  
  
 
  
Eligibility criteria 
X 
  
  
  
 
  
Medical  history 
X 
  
  
  
 
  
Physical 
examination 
X 
  
  
  
 
  
Vital signs 
X 
X 
X 
  
 
  
12 lead ECG 
X 
  
X 
  
 
  
Transesophageal 
echocardiogram 
X1 
X 
  
  
 
  
Transthoracic 
echocardiogram 
X1 
  
X 
X 
X 
X 
Complete 
blood 
count2 
X 
  
X 
  
 
  
Renal function test3 
X 
  
X 
  
 
  
CK/CK-MB／BNP 
X 
  
X 
  
 
  
NYHA 
Functional 
class 
X 
  
X 
X 
X 
X 
Device performance 
evaluation 
  
X 
  
  
 
  
Medication4 
X 
X 
X 
X 
X 
X 
Adverse events5 
  
X 
X 
X 
X 
X 

Note: 
1. 
TTE within 45 days and TEE within 120 days prior screening frame can be accepted. 
2. 
Complete blood count includes: RBC, WBC, PLT, Hb 
3. 
Renal function test include serum creatinine and urea nitrogen 
4. 
For medication, only anticoagulation drugs and antiplatelet drugs are recorded 
5. 
Adverse events include adverse events, severe adverse events and complications.