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Dragonfly-M Early Feasibility Study

Primary Purpose

Mitral Regurgitation

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dragonfly mitral valve repair system
Sponsored by
Hangzhou Valgen Medtech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Regurgitation focused on measuring mitral regurgitation, TMVr

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

  • The Second Affiliated Hospital of Zhejiang University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DragonFly-M

Arm Description

Experimental group is allocated to use novel mitral valve repair system manufactured by Hangzhou Valgen Meditech Co., Ltd

Outcomes

Primary Outcome Measures

Incidence of acute procedural success
The acute procedural success is defined as successful Dragonfly 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
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 device failure.

Secondary Outcome Measures

All-cause mortality
Death from any cause
Cardiovascular mortality
Death from cardiac causes
Incidence of serious adverse event (SAE）
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.
NYHA
NYHA functional class
Technical success
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.
Device success
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.

Full Information

First Posted
August 23, 2020
Last Updated
March 26, 2022
Sponsor
Hangzhou Valgen Medtech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04528576
Brief Title
Dragonfly-M Early Feasibility Study
Official Title
Dragonfly-M Transcatheter Mitral Valve Repair System Early Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 23, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Valgen Medtech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To establish the safety and effectiveness of the DragonFly transcatheter mitral valve repair system in symptomatic patients with moderate to severe and severe mitral regurgitation who have been determined to be at an high risk of mortality with mitral valve surgery by the cardiac surgeon with concurrence by the local Heart Team
Detailed Description
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 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation
Keywords
mitral regurgitation, TMVr

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The clinical trial was designed as a single group assignment study. The participants with moderate to severe and severe mitral valve regurgitation will receive a transseptal mitral valve repair using Dragonfly mitral valve repair system.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DragonFly-M
Arm Type
Experimental
Arm Description
Experimental group is allocated to use novel mitral valve repair system manufactured by Hangzhou Valgen Meditech Co., Ltd
Intervention Type
Device
Intervention Name(s)
Dragonfly mitral valve repair system
Intervention Description
With transesophageal echocardiographic guidance,implanting clip using Dragonfly mitral valve repair system
Primary Outcome Measure Information:
Title
Incidence of acute procedural success
Description
The acute procedural success is defined as successful Dragonfly 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
Time Frame
1 month
Title
Incidence of major adverse event (MAE) at 30 days
Description
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 device failure.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
Death from any cause
Time Frame
6 months
Title
Cardiovascular mortality
Description
Death from cardiac causes
Time Frame
6 months
Title
Incidence of serious adverse event (SAE）
Description
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.
Time Frame
6 months
Title
NYHA
Description
NYHA functional class
Time Frame
6 months
Title
Technical success
Description
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.
Time Frame
Immediately after procedure
Title
Device success
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 yrs Moderate-to-severe (3+) or severe (4+) mitral valve regurgitation on transthoracic or transesophageal echocardiography, and confirmed by echocardiographic core laboratory The patient is on optimal guideline directed medical therapy for heart failure and remains symptomatic. 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. Anatomically suitable for mitral valve repair and can be treated by Dragonfly confirmed by both site investigators, echocardiographic core laboratory, and the eligibility committee. Transseptal catheterization and femoral vein access is determined to be feasible Life expectancy ≥ 12 months 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: History of heart transplantation, prior mitral valve replacement surgery. or transcatheter mitral valve procedure; 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 Evidence of calcification or significant cleft in the grasping area LVEF < 20% LVESD≥ 60mm; Mobile leaflet length<10mm 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. Echocardiographic evidence of intracardiac mass, thrombus or vegetation; Severe non-mitral valve disease requiring treatment . Severe pulmonary artery hypertension (sPAP>70mmHg) Severe right ventricular dysfunction; Active endocarditis or previous mitral valve endocarditis; Active rheumatic heart disease or leaflets degenerated from rheumatic disease Severe untreated coronary artery stenosis requiring revascularization; or with other cardiovascular disease requiring surgical treatment； Extreme frailty Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis and any other structural heart disease causing heart failure other than dilated cardiomyopathy; Renal failure requiring dialysis; 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; Evidence of an acute myocardial infarction in the prior 4 weeks; Evidence of a shock in the prior 90 days; Any percutaneous cardiac intervention or carotid surgery or any cardiac surgery within the 30 days prior to randomization; Evidence of acute peptic ulcer upper or gastrointestinal hemorrhage in the prior 90 days; Severe symptomatic carotid artery stenosis over 70% confirmed by echocardiography; 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; Life expectancy ≤ 12 months; Subject participating in an investigational drug or another device study within the past 1 month; In the judgment of the investigator, subjects may not complete the trial according to poor compliance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jianan Wang, PhD
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36338402
Citation
Liu X, Chen M, Han Y, Pu Z, Lin X, Feng Y, Xu K, Lam YY, Lim DS, Wang J. First-in-Human Study of the Novel Transcatheter Mitral Valve Repair System for Mitral Regurgitation. JACC Asia. 2022 Jun 21;2(3):390-394. doi: 10.1016/j.jacasi.2022.03.010. eCollection 2022 Jun.
Results Reference
derived

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Dragonfly-M Early Feasibility Study

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