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Off-pump pulmonary valvectomy in pulmonary atresia with intact ventricular septum: a randomized clinical trial

A prospective, randomised trial to evaluate clinical effectiveness following off-Pump pulmonary valvectomy in pulmonary atresia with intact ventricular septum

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035632
Enrollment
Unknown
Registered
2020-08-15
Start date
2020-09-10
Completion date
Unknown
Last updated
2020-08-31

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

Conditions

pulmonary atresia with intact ventricular septum

Interventions

off-pump group:off-pump pulmonary vulvectomy
on-pump group:on-pump pulmonary vulvectomy

Sponsors

Shanghai Children Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. PA/IVS; 2. Aged - 4 and without RVDCC; 4. Preoperative echocardiography showed that cardiac function was more than 60%; 5. B-type natriuretic peptide (BNP) and troponin were normal or slightly abnormal before operation; 6. Good compliance of family members.

Exclusion criteria

Exclusion criteria: 1. There were any other extracardiac malformations and chromosomal abnormalities; 2. There were obvious neurological symptoms or signs before operation; 3. Patients with low follow-up rate in remote areas; 4. There were contraindications to the use of conventional drugs in the ICU; 5. Patient's unwillingness to sign informed consent.

Design outcomes

Primary

MeasureTime frame
blood flow velocity at pulmonary orifice ;

Secondary

MeasureTime frame
cerebral oxygen metabolism;cardiac function index;liver, kidney function index;

Countries

China

Contacts

Public ContactXiaomin He

Shanghai Children's Medical Center

mrxmhe@163.com+86 18017762699

Outcome results

None listed

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