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A prospective single-center randomized controlled trial: "guidewire leading" in percutaneous closure of ventricular septal defect

A prospective single-center randomized controlled trial: "guidewire leading" in percutaneous closure of ventricular septal defect

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-ICR-15006582
Enrollment
Unknown
Registered
2015-06-14
Start date
2015-06-11
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

ventricular septal defect

Interventions

Test group:use "guide wire leading" method
Control group:use traditional method

Sponsors

Wuhan Asia Heart Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. age >=3 years, body weight >=10Kg; 2. diagnosis of VSD without hemodynamic abnormalities, no other cardiac malformations or diseases of vital organs; 3. pmVSD size =3 mm; 4. a distance of >2 mm from the VSD to the aortic valve, >2 mm from the VSD to the tricuspid. No aortic sinus prolapse into the VSD. No aortic regurgitation. No moderate or severe tricuspid regurgitation; 5. If membranous aneurysm exists, the anuerysm do not affect the right ventricular outflow tract; 6. muscular VSD size> 3mm, a distance of >=3 mm from the apex; 7. The patient voluntarily accepts interventional therapy and informs the consent.

Exclusion criteria

Exclusion criteria: 1. merger with moderate or more severely pulmonary hypertension; 2. combines with other heart diseases that requires surgical correction; 3. infection has not been effectively controlled.

Design outcomes

Primary

MeasureTime frame
shealth in position;procedure success;

Secondary

MeasureTime frame
duration of radiation;duration of operation;

Countries

China

Contacts

Public ContactZhang Gangcheng
zgc@wahh.com.cn+86 18963980946

Outcome results

None listed

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