Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect

NCT02644330 | Unknown Phase 2 DMC

• 1 other identifier: 2015-ZH39
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of minimally invasive transthoracic device closure of ventricular septal defect. This is a multi-center randomized controlled trial. Because of the characteristics of this surgical clinical trials, surgeons, ultrasonic department doctors, anesthesiologists, operating room nurses and intensive care unit nurses are all need to be informed. Therefore the results of this trial need to be system evaluated through objective methods to reduce bias.

Conditions

Perimembranous Ventricular Septal Defect

Outcome Measures

Primary Outcomes (1)

• the success rate of the operation

  The definition of a successful operation: shunt disappeared

  index procedure (day 0)

Secondary Outcomes (7)

• adverse events

  12 months

• thoracic fluid volume

  index procedure (day 0)

• blood transfusion

  index procedure (day 0)

• operating time

  index procedure (day 0)

• postoperative ventilator support time

  index procedure (day 0)

Study Arms (2)

surgical group

ACTIVE COMPARATOR

The patients in Group A (surgical group) underwent surgical repair with cardiopulmonary bypass

Procedure: surgical repair

closure group

EXPERIMENTAL

The patients in Group B (closure group) underwent minimally invasive transthoracic device closure.

Procedure: transthoracic device closure

Interventions

transthoracic device closure PROCEDURE

minimally invasive transthoracic device closure

closure group

surgical repair PROCEDURE

surgical repair with cardiopulmonary bypass

surgical group

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥3 months
• Patients with isolated perimembranous ventricular septal defect with hemodynamic abnormalities. Diameter of the defect is greater than 3mm, and less than 10mm

You may not qualify if:

• Para adverse ventricular septal defect
• Muscular ventricular septal defect, subpulmonic ventricular septal defect and septal leaflet posterior atrioventricular canal ventricular septal defect
• Patients with severe pulmonary hypertension in right-to-left shunt
• Patients with obvious aortic valve prolapse, with moderate or severe aortic regurgitation
• Infective endocarditis, and heart cavity neoplasm
• Patients with other cardiovascular malformations, which require surgery with cardiopulmonary bypass to correct at the same period

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (3)

Henan Province People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

XiangYa Hospital CentralSouth University

Changsha, Hunan, 410008, China

RECRUITING

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

RECRUITING

MeSH Terms

Interventions

Wound Healing

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Study Officials

• Xiangbin Pan, Dr

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangbin Pan, Dr

CONTACT

010-88396666; fuwaiyiyuan28@163.cpm

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician in pediatric cardiac surgery

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: December 31, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2017
• Last Updated: December 31, 2015

Record last verified: 2015-12

Locations

CN (3)