Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02644330
• Collaborator: (none)
• Enrollment: 100
• Locations: 3
• Arms: 2
• Duration (Months): 24
• Patients Per Site: 33.3
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Perimembranous Ventricular Septal Defect	Procedure: transthoracic device closure; Procedure: surgical repair	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of Minimally Invasive Transthoracic Device Closure in the Treatment of Patients With Perimembranous Ventricular Septal Defect
• Study Start Date: Oct 1, 2015
• Anticipated Primary Completion Date: Oct 1, 2016
• Anticipated Study Completion Date: Oct 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. the success rate of the operation [index procedure (day 0)]

   The definition of a successful operation: shunt disappeared

Secondary Outcome Measures

1. adverse events [12 months]

   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

2. thoracic fluid volume [index procedure (day 0)]

3. blood transfusion [index procedure (day 0)]

4. operating time [index procedure (day 0)]

   time cost from cut the skin to complete closure of the sternum

5. postoperative ventilator support time [index procedure (day 0)]

6. postoperative hospital stay [7 days after operation or before discharge]

7. costs [7 days after operation or before discharge]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henan Province People's Hospital	Zhengzhou	Henan	China	450003
2	XiangYa Hospital CentralSouth University	Changsha	Hunan	China	410008
3	The First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan	China	650032

Sponsors and Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

• Principal Investigator: Xiangbin Pan, Dr, Fuwai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pan Xiangbin, Associate chief physician in pediatric cardiac surgery, Chinese Academy of Medical Sciences, Fuwai Hospital
• ClinicalTrials.gov Identifier: NCT02644330
• Other Study ID Numbers: 2015-ZH39
• First Posted: Dec 31, 2015
• Last Update Posted: Dec 31, 2015
• Last Verified: Dec 1, 2015

• Additional relevant MeSH terms: Heart Septal Defects; Heart Septal Defects, Ventricular

Study Results

No Results Posted as of Dec 31, 2015