Clinical Assessment of Perfusion Techniques During Repair of Coarctation With Aortic Arch Hypoplasia in Infants

Meshalkin Research Institute of Pathology of Circulation

Status: Unknown

Conditions: Coarctation of Aorta

Treatments: Procedure: Surgical repair of coarctation of aorta

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02835703

PTAAR

Details and patient eligibility

About

The purpose of this study is to evaluate safety and efficacy of three main perfusion methods in surgical repair of coarctation of aorta with aortic arch hypoplasia in infants.

Full description

Three perfusion techniques of visceral protection will be assessed - deep hypothermic circulatory arrest, selective antegrade cerebral perfusion and double arterial cannulation (perfusion of brachiocephalic artery with thoracic descending aorta by two arterial cannulas)

Enrollment: 45 estimated patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• coarctation with severe aortic arch hypoplasia (distal aortic arch z-score < -2)
• coarctation of aorta with septal defects

Exclusion criteria

• coarctation with mild aortic arch hypoplasia (distal aortic arch z-score > -2)
• complex congenital heart diseases including aortic arch hypoplasia (e.g. transposition of great arteries, double oulet right ventricle, atrioventricular septal defect, Shone's complex)
• univentricular and duct-dependent heart defects
• aortic valve and/or mitral valve stenosis/hypoplasia (aortic valve or mitral valve z-score < -2.0)
• left ventricular dysfunction (left ventricle ejection fraction < 60%)
• congenital renal or central nervous system anomalies
• related infectious diseases
• prematurity (gestational age < 37 weeks)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Deep hypothermic arrest

Active Comparator group

Description:

Surgical repair of coarctation of aorta under deep hypothermic circulatory arrest

Treatment:

Procedure: Surgical repair of coarctation of aorta

Selective antegrade cerebral perfusion

Active Comparator group

Description:

Surgical repair of coarctation of aorta using selective antegrade cerebral perfusion

Treatment:

Procedure: Surgical repair of coarctation of aorta

Double arterial cannulation

Active Comparator group

Description:

Surgical repair of coarctation of aorta using cerebral antegrade perfusion with descending aortic cannulation

Treatment:

Procedure: Surgical repair of coarctation of aorta