Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect

A Randomized Controlled Trial of Minimally Invasive Transthoracic Device Closure in the Treatment of Patients With Perimembranous Ventricular Septal Defect

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.

Study Overview

• Status: Unknown
• Conditions: Perimembranous Ventricular Septal Defect
• Intervention / Treatment: Procedure: surgical repair; Procedure: transthoracic device closure

Detailed Description

Several examinations need to be done in all the patients, including X-ray, electrocardiogram, echocardiogram, blood routine examination, liver and kidney function, electrolytes, coagulation function and infectious index checks. And they will be divided into two groups after they have obtained informed consent: surgical group (50 cases); closure group (50 cases). If the closure failed, the patients in closure group will be converted to surgical repair with cardiopulmonary bypass .

Recheck X-ray, electrocardiogram, echocardiogram, blood routine examination, liver and kidney function and electrolytes need to be done in all the patients two days after operation. The patients were followed up by X-ray, electrocardiogram, echocardiogram at the first month, third month, sixth month and the first year.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Xiangbin Pan, Dr; Phone Number: 010-88396666; Email: fuwaiyiyuan28@163.cpm

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Henan province people's hospital
  • Hunan
    • Changsha, Hunan, China, 410008
      • Recruiting
      • XiangYa Hospital CentralSouth University
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • Recruiting
      • The First Affiliated Hospital of Kunming Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: surgical group; The patients in Group A (surgical group) underwent surgical repair with cardiopulmonary bypass	Procedure: surgical repair; surgical repair with cardiopulmonary bypass
Experimental: closure group; The patients in Group B (closure group) underwent minimally invasive transthoracic device closure.	Procedure: transthoracic device closure; minimally invasive transthoracic device closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the success rate of the operation	The definition of a successful operation: shunt disappeared	index procedure (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events	death, cardiac perforation, cardiac tamponade, emerging tricuspid regurgitation, emerging aortic regurgitation, arrhythmias (third-degree atrioventricular block, complete bundle branch block), postoperative residual shunt (refers to the residual shunt, which diameter greater than 2mm or flow rate greater than 3m/s), infective endocarditis, postoperative murmur	12 months
thoracic fluid volume		index procedure (day 0)
blood transfusion		index procedure (day 0)
operating time	time cost from cut the skin to complete closure of the sternum	index procedure (day 0)
postoperative ventilator support time		index procedure (day 0)
postoperative hospital stay		7 days after operation or before discharge
costs		7 days after operation or before discharge

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Investigators: Principal Investigator: Xiangbin Pan, Dr, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: December 28, 2015
• First Submitted That Met QC Criteria: December 30, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Estimate): December 31, 2015
• Last Update Submitted That Met QC Criteria: December 30, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects; Heart Septal Defects, Ventricular
• Other Study ID Numbers: 2015-ZH39