Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429579
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-05
Brief Title:
Potts-shunt for the Treatment of Pediatric Patients With Severe Pulmonary Hypertension
Sponsor:
China National Center for Cardiovascular Diseases
Organization:
China National Center for Cardiovascular Diseases
Study Overview
Official Title:
Multicenter Prospective and Exploratory Study of Potts-shunt for the Treatment of Pediatric Patients With Severe Pulmonary Hypertension
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center perspective and exploratory study aimed at evaluating the 3-years clinical outcome of Potts-shunt procedure for pediatric patients with severe pulmonary artery hypertension PAH The included criteria are as followed 16 months age 18 years 2 ESC 2022 Group I PAH 3 Have received standardized drug therapy for at least 6-9 months and still remain at intermediate to highhigh-risk status of the criteria of ESC2022 4 Presenting with significant clinical manifestations ie progressive symptomssyncope historygrowth and development restriction etc 5 Informed consent form signed by the patient and their guardian The excluded criteria are as followed 1 ESC 2022 Group II-V PAH 2 Poor right ventricular function RVEF 25 or RVFAC 20 3 Deteriorated general condition requiring ICU resuscitation or ECMO assistance 4 Pulmonary artery pressuremain arterial pressure ratio 07 5 Six-minute walk distance 150 meters only applicable to patients aged 8 and above 6 No significant improvement in RVEF under triple drug therapy All of the pediatric patients with severe PAH who attend to pediatric cardiac outpatient clinic and meet the designed included criteria and excluded criteria will be enrolled in this study All of the participants will be divided into two groups Potts-shunt combined with conventional drug therapy group and only conventional drug therapy group according to their individual health status ie some contraindications of surgery and their or their parents aspiration for Potts-shunts procedure Follow-up is designed eight-times follow-up at the time of Potts-shunt procedure post-operative ICU period one month three months six months one year two years and three years after Potts-shunt procedure or the rejection of Potts-shunt procedure The items of follow-up include state of survival whether or not have the lung transplantation LTx clinical manifestation laboratory examination function of right ventricle detected by echocardiogram and cardiac magnetic resonance imaging and the pulmonary circulation pressure detected by right heart catheterization or Swan-Ganz catheterization Primary outcome is the incidence rates of death or LTx three-years after Potts-shunt Secondary outcomes are as followed 1 Number and incidence rate of postoperative complications in patients undergoing Potts-shunt procedure 2 Three-year WHO cardiac functional and 6-minute walk distance after Potts-shunt procedure 3 the NT-ProBNP levels three-years after Potts-shunt procedure 4 Right ventricular function on echocardiography three years after Potts-shunt procedure 5 Right ventricular function on cardiac magnetic resonance imaging three years after Potts-shunt procedure 6 Pulmonary circulation pressure measured by right heart catheterization or Swan-Ganz catheterization three years after Potts-shunt procedure 7 Three-year mortality or LTx incidence rates after only conventional drug therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None