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Research of the operation standards, long-term efficacy and new technic clinical application of interventional therapy for the congenital heart diseases and valvular heart diseases

Research of the operation standards, long-term efficacy and new technic clinical application of interventional therapy for the congenital heart diseases and valvular heart diseases

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-11001239
Enrollment
Unknown
Registered
2011-03-22
Start date
2008-01-01
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

atrial septal defect (ASD), ventricular septal defect (VSD), patent ductus arteriosus (PDA), pulmonary stenosis (PS), mitral stenosis (MS)

Interventions

MS group:interventional therapy
PDA group:interventional therapy
ASD group:interventional therapy
VSD group:interventional therapy
PS group:interventional therapy

Sponsors

Guangdong Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 65 Years

Inclusion criteria

Inclusion criteria: Retrospective study:Cases of continuous interventional treatment before December 31, 2007, including the success and failure cases, no matter how long the follow-up time it is. Prospective study: Cases of intervention treatment during January 2008 to December 2010 with the following conditions: 1-ASD: 1) Ostium secundum defect with the evidence of right ventricular volume overload; 2) ASD reserved after surgery; 3) Ostium secundum defect with residual shunt after surgery; 4) Diameter of defect >=5mm, =6.67kpa (50mmHg); 2) Typical pulmonary stenosis. ECG show the enlargement of right ventricular. And its imaging show the Pulmonary artery expansion. The different pressure between the both side of the pulmonary valve is 4.67-6.67kpa (35-50mmHg). 5-MS: 1) Rheumatic mitral stenosis patient definited by clinical diagnoses; 2) Mitral valve area <=1.5cm2; 3) Wilkins ultrasound scoring <=8; 4) Degree of mitral regurgitation is below class II. (Colour Doppler Echocardiography); 5) Combine with aortic regurgitation: below class II(Colour Doppler Echocardiography); 6) No aortic valve stenosis; 7) No active rheumatic; 8) NYHA class II ~ IV (Cardiac function); 9) Patients with atrial fibrillation but without left ventricular thrombus proved by Transesophageal Echocardiogram (TEE).

Exclusion criteria

Exclusion criteria: Retrospective study: Cases of continuous intervention before December 31, 2007, combine with the other abnormality at the same time. Prospective study: Cases of interventional treatment during January 2008 to December 2010 with the following conditions: 1-ASD 1) Ostium secundum defect with other congenital cardio-abnormality which require a surgical correction. 2) Ostium secundum defect combine with other congenital cardio-abnormality for the interventional treatment at the same time. 3) Venous sinus type ASD 4) Severe pulmonary hypertension causes right to left shunt 5) Routine cardiac catheterization can not be tolerated. 2-VSD 1) weight8 6) Patient combine with early pregnancy (<3 months) 7) Patient combine with other congenital cardiovascular malformations 8) Patient combine with other serious organ dysfunction except the heart. 9) Combine with other heart malformation such as: dextrocardia or significant scoliosis .

Design outcomes

Primary

MeasureTime frame
ASD Safety: No deaths or serious complications;PDA: Evaluate the efficacy by PDA imaging;PS Safety;MS safety;PDA: Evaluate the efficacy by PDA echocardiogram;PDA Safety: No deaths or serious complications;PS efficacy;MS efficacy;VSD: Evaluate the efficacy by VSD imaging;VSD: Evaluate the efficacy by VSD echocardiogram;VSD Safety: No deaths or serious complications;ASD Efficacy: ASD closure is successful or no;

Countries

China

Contacts

Public ContactShuguang LIN
xiaying@lifetechmed.com+86 20 83845626

Outcome results

None listed

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