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A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions

Primary Purpose

Atrial Septal Defect

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Guidewire for echo-guided interventions
Cook lunderquist guidewire
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Septal Defect focused on measuring ASD, Atrial septal defects, amplatzer

Eligibility Criteria

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

Inclusion Criteria:

  1. age≥2yrs, diameter of defect≥5 mm, central ASD with increased volume load of right heart.
  2. edge of defect is ≥5 mm from coronary sinus, superior and inferior vena cava, and pulmonary vein, and≥7 mm from atrioventricular valve.
  3. diameter of atrial septal > left-atrium-side diameter of occlude.
  4. participants or guardians who can understand the purpose of this trial and voluntarily participate in and sign the informed consent form.

Exclusion Criteria:

  1. Primary atrial septal defect.
  2. Sinus venosus atrial septal defects.
  3. Accompany with endocarditis or hemorrhagic risks.
  4. thrombosis in targeting area or venous thrombosis in inserting site.
  5. severe pulmonary artery hypertension generated right-to-left shunt.
  6. severe myocardial or valve disease unrelated with ASD.
  7. suffered infection diseases or developing infection diseases within 1 month, thrombosis in left atrium or left appendage, part or total anomalous pulmonary venous drainage.

Sites / Locations

  • Structural Heart Disease Center, Fuwai HospitalRecruiting
  • Fuwai Huazhong Cardiovascular Hospital
  • Xinjiang People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Group

Control Group

Arm Description

Experimental group is allocated to use novel interventional guidewire for the echocardiography guided percutaneous interventions for ASD.

Control Group is allocated to use Cook lunderquist guidewire for the echocardiography guided percutaneous interventions for ASD.

Outcomes

Primary Outcome Measures

success rate
The primary outcome will be the success rate, which is defined by the principles below: guidewire can successfully access to left atrium through ASD. sheath can successfully access to left atrium guided by guidewire and not fall into right atrium after guidewire pullout. guidewire can be successfully pulled out. The secondary outcome will be duration of procedure, times of arrhythmia, times of misguided to tricuspid valve, cardiac perforation, cardiac tamponed, complications in peripheral vessels.

Secondary Outcome Measures

Incidence of major adverse events(MAE)
MAE definition: Any complications related to devices or surgeries, including but not limited to: death, emergency surgery, severe cardiac tamponade requiring pericardiocentesis or operation, hemorrhage, stroke related to operation.

Full Information

First Posted
September 18, 2019
Last Updated
September 18, 2019
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04096924
Brief Title
A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions
Official Title
A Randomized Multicenter Comparison Trial to Evaluate the Effectiveness and Safety of the Guidewire for Echo-guided Interventions in Treating ASD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 7, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
May 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital

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
Prospective randomized multicenter trial of about 100 subjects enrolled in 3-5 centers. Patients will be randomized to two groups in equal proportion (50 in each). To precise the function of this device on reducing technical difficulties and conquering learning curves, it is required that the doctor should be able to independently do echo-guided percutaneous interventions and his cases should be more than 20 but less than 100. Experimental group is allocated to use novel interventional guidewire for echocardiography guided percutaneous interventions for ASD, control group will be treated by cook lunderquist guidewire. If echo-guided procedure does not work well, the procedure will be immediately replaced by conventional procedure guided by radiology. To evaluate the effectiveness and safety comprehensively, variables are defined as success rate, duration of procedure, times of arrhythmia, times of misguided to tricuspid valve, cardiac perforation, cardiac tamponed, complications in peripheral vessels etc.
Detailed Description
This is a prospective blinded randomized multicenter comparison clinical trial followed the design of superiority trial to compare the effectiveness and safety of the guidewire for echo-guided interventions designed by Hangzhou Dexin Medical Technological Company with other similar products. This trial will enroll about 100 subjects from 3-5 centers. Patients will be randomized to two groups in equal proportion (50 in each). Proposal recruiting period is 18 months and follow-up will be performed for 30 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Septal Defect
Keywords
ASD, Atrial septal defects, amplatzer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Experimental group is allocated to use novel interventional guidewire for the echocardiography guided percutaneous interventions for ASD.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Control Group is allocated to use Cook lunderquist guidewire for the echocardiography guided percutaneous interventions for ASD.
Intervention Type
Device
Intervention Name(s)
Guidewire for echo-guided interventions
Intervention Description
Under echocardiography guided treatment of ASD with a novel interventional guidewire
Intervention Type
Device
Intervention Name(s)
Cook lunderquist guidewire
Intervention Description
Subjects with ASD treated with amplatzer using the Cook lunderquist guidewire.
Primary Outcome Measure Information:
Title
success rate
Description
The primary outcome will be the success rate, which is defined by the principles below: guidewire can successfully access to left atrium through ASD. sheath can successfully access to left atrium guided by guidewire and not fall into right atrium after guidewire pullout. guidewire can be successfully pulled out. The secondary outcome will be duration of procedure, times of arrhythmia, times of misguided to tricuspid valve, cardiac perforation, cardiac tamponed, complications in peripheral vessels.
Time Frame
Immediately after treatment
Secondary Outcome Measure Information:
Title
Incidence of major adverse events(MAE)
Description
MAE definition: Any complications related to devices or surgeries, including but not limited to: death, emergency surgery, severe cardiac tamponade requiring pericardiocentesis or operation, hemorrhage, stroke related to operation.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age≥2yrs, diameter of defect≥5 mm, central ASD with increased volume load of right heart. edge of defect is ≥5 mm from coronary sinus, superior and inferior vena cava, and pulmonary vein, and≥7 mm from atrioventricular valve. diameter of atrial septal > left-atrium-side diameter of occlude. participants or guardians who can understand the purpose of this trial and voluntarily participate in and sign the informed consent form. Exclusion Criteria: Primary atrial septal defect. Sinus venosus atrial septal defects. Accompany with endocarditis or hemorrhagic risks. thrombosis in targeting area or venous thrombosis in inserting site. severe pulmonary artery hypertension generated right-to-left shunt. severe myocardial or valve disease unrelated with ASD. suffered infection diseases or developing infection diseases within 1 month, thrombosis in left atrium or left appendage, part or total anomalous pulmonary venous drainage.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangbin Pan, MD,Ph.D
Phone
010-88396666
Email
xiangbin428@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangbin Pan, MD,Ph.D
Organizational Affiliation
Chinese Academy of Medical Sciences, Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Structural Heart Disease Center, Fuwai Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangbin Pan, MD,Ph.D
Phone
010-88396666
Email
xiangbin428@hotmail.com
Facility Name
Fuwai Huazhong Cardiovascular Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taibin Fan, MD, Ph.D
Facility Name
Xinjiang People's Hospital
City
Urumqi
State/Province
Xinjiang
Country
China
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32847382
Citation
Kong P, Zhao G, Zhang Z, Zhang W, Fan T, Han Y, Pang K, Wang S, Zhang F, Wang W, Hu S, Pan X. Novel Panna Guide Wire Facilitates Percutaneous and Nonfluoroscopic Procedure for Atrial Septal Defect Closure: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2020 Sep;13(9):e009281. doi: 10.1161/CIRCINTERVENTIONS.120.009281. Epub 2020 Aug 27.
Results Reference
derived

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A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions

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