NCT02374229

Ablation of the Pulmonary Artery With High Pulmonary Hypertension During Mitral Valve Surgery

Surgical Ablation of Ganglion Plexuses of the Pulmonary Artery in Patients With Valvular Heart Disease, Complicated by High Pulmonary Hypertension May Reduce Its Degree.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this prospective randomized study was to evaluate the effectiveness and safety of the original ablation procedures ganglion plexus pulmonary artery with simultaneous correction of valvular heart disease, complicated by high pulmonary hypertension.

Detailed description

Pulmonary hypertension is a serious condition, the severity of which is often underestimated. About 10% of significant mitral heart disease complicated by high pulmonary hypertension (more than 60 mm Hg). Up to 70% of patients retain this level of pulmonary hypertension after successful treatment of heart valve disease.The quality of life of patients with persistent high pulmonary hypertension is significantly lower than in patients with mild to moderate degree. Risks of recurrent tricuspid insufficiency and right ventricular dysfunction is much higher. Despite the use of modern drug therapy of pulmonary hypertension in patients with valvular heart disease satisfactory clinical effect is achieved only in a small number of patients. Our team proposed a new original method of ablation of the pulmonary artery with simultaneous open cardiac surgery correction of mitral heart disease in patients with high baseline pulmonary hypertension.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
PROCEDURE	Surgical ablation of ganglion plexus pulmonary artery.	Performed ablation zone pulmonary artery bifurcation, at 2mm proximal direction and a distal direction in the left and right branches of the pulmonary artery using the electrophysiological device Atricure.
PROCEDURE	mitral valve surgery	The standard procedure for mitral regurgitation or stenosis, the procedures will be a valve repair or mitral valve replacement, depending upon the particular morphological condition of the mitral valve.

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-02-27
• Last updated: 2015-09-23

Locations

1 site across 1 country: Russia