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Feasibility and Safety of Ventricular Septal Defects Closure via Transradial Approach:a prospective single center randomized controlled study

Feasibility and Safety of Ventricular Septal Defects Closure via Transradial Approach:a prospective single center randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020700
Enrollment
Unknown
Registered
2019-01-14
Start date
2019-02-01
Completion date
Unknown
Last updated
2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Septal Defects

Interventions

transradial group:Puncture the radial artery combined with femoral vein
transfemoral group:Puncture the femoral artery combined with femoral vein

Sponsors

Department of Cardiology, Changhai Hospital, Second Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age = 18 years old; 2. Perimembranous ventricular septal defect; 3. The upper margin of the defect was more than 2 mm from the right aortic valve, and there was no right aortic valve detachment into the defect and aortic valve regurgitation; 4. The location of the defect was 9-12 points in transthoracic echocardiography aortic short axis section; 5. The maximum defect diameter was less than 14 mm.

Exclusion criteria

Exclusion criteria: 1. Infectious endocarditis; 2. Complicated with other cardiac malformations requiring surgical intervention; 3. Severe pulmonary hypertension with bidirectional shunt; 4. Haemorrhagic tendency and obvious abnormal liver and kidney function; 5. Cardiac insufficiency can not tolerate operation.

Design outcomes

Primary

MeasureTime frame
device implantation success rate;

Countries

China

Contacts

Public ContactXianxian Zhao

Department of Cardiology, Changhai Hospital, Second Military Medical University

twd952@126.com+86 13651757897

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026