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

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ClinicalTrials.gov Identifier: NCT04096924
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Condition or disease Intervention/treatment Phase
Atrial Septal Defect Device: Guidewire for echo-guided interventions Device: Cook lunderquist guidewire Not Applicable

Detailed Description:
  1. 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.
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Comparison Trial to Evaluate the Effectiveness and Safety of the Guidewire for Echo-guided Interventions in Treating ASD
Actual Study Start Date : July 7, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : May 30, 2020

Arm Intervention/treatment
Experimental: Treatment Group
Experimental group is allocated to use novel interventional guidewire for the echocardiography guided percutaneous interventions for ASD.
Device: Guidewire for echo-guided interventions
Under echocardiography guided treatment of ASD with a novel interventional guidewire

Active Comparator: Control Group
Control Group is allocated to use Cook lunderquist guidewire for the echocardiography guided percutaneous interventions for ASD.
Device: Cook lunderquist guidewire
Subjects with ASD treated with amplatzer using the Cook lunderquist guidewire.




Primary Outcome Measures :
  1. success rate [ Time Frame: Immediately after treatment ]

    The primary outcome will be the success rate, which is defined by the principles below:

    1. guidewire can successfully access to left atrium through ASD.
    2. sheath can successfully access to left atrium guided by guidewire and not fall into right atrium after guidewire pullout.
    3. 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 :
  1. Incidence of major adverse events(MAE) [ Time Frame: 1 month ]
    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.



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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096924


Contacts
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Contact: Xiangbin Pan, MD,Ph.D 010-88396666 xiangbin428@hotmail.com

Locations
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China, Beijing
Structural Heart Disease Center, Fuwai Hospital Recruiting
Beijing, Beijing, China
Contact: Xiangbin Pan, MD,Ph.D    010-88396666    xiangbin428@hotmail.com   
China, Henan
Fuwai Huazhong Cardiovascular Hospital Not yet recruiting
Zhengzhou, Henan, China
Contact: Taibin Fan, MD, Ph.D         
China, Xinjiang
Xinjiang People's Hospital Active, not recruiting
Urumqi, Xinjiang, China
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
Investigators
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Principal Investigator: Xiangbin Pan, MD,Ph.D Chinese Academy of Medical Sciences, Fuwai Hospital

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Responsible Party: Pan Xiangbin, Chief, Department of Structural Heart Disease, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT04096924     History of Changes
Other Study ID Numbers: HYQ001
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital:
ASD
Atrial septal defects
amplatzer
Additional relevant MeSH terms:
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Heart Septal Defects
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities