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

Phase 1

• Conditions: Pulmonary Hypertension
• Interventions: Procedure: mitral valve surgery; Procedure: Surgical ablation of ganglion plexus pulmonary artery.

• Registration Number: NCT02374229
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief 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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-02-27
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23
• Primary Completion: 2016-11
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with mitral stenosis or insufficiency complicated by high pulmonary hypertension (mean pulmonary artery pressure in invasive monitoring more than 35 mm Hg), which are subject to surgical treatment.

Exclusion Criteria

• pulmonary stenosis;
• pulmonary embolism in history;
• congenital heart disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The control group	mitral valve surgery	Procedure:mitral valve surgery. Will include 15 patients with mitral stenosis or insufficiency subject to correction, complicated by high pulmonary hypertension. Patients will be made standard procedure correction mitral valve disease without pulmonary artery denervation. For mitral regurgitation or stenosis, the procedures will be a valve repair or mitral valve replacement only.
The study group	Surgical ablation of ganglion plexus pulmonary artery.	Procedure: mitral valve surgery, surgical ablation of ganglion plexus pulmonary artery. Will include 15 patients with mitral stenosis or insufficiency subject to correction, complicated by high pulmonary hypertension. During the operation, a standard surgical procedure for the treatment of heart valve disease will be complemented by the ablation zone of bifurcation of the pulmonary artery, surgical ablation of ganglion plexus pulmonary artery. For mitral regurgitation or stenosis, the procedures will be a valve repair or mitral valve replacement. Procedure will be considered effective in the face of declining average pressure in the pulmonary artery for invasive monitoring of 10mm Hg and more.
The study group	mitral valve surgery	Procedure: mitral valve surgery, surgical ablation of ganglion plexus pulmonary artery. Will include 15 patients with mitral stenosis or insufficiency subject to correction, complicated by high pulmonary hypertension. During the operation, a standard surgical procedure for the treatment of heart valve disease will be complemented by the ablation zone of bifurcation of the pulmonary artery, surgical ablation of ganglion plexus pulmonary artery. For mitral regurgitation or stenosis, the procedures will be a valve repair or mitral valve replacement. Procedure will be considered effective in the face of declining average pressure in the pulmonary artery for invasive monitoring of 10mm Hg and more.

Primary Outcome Measures

Name	Time	Method
Death of the patient	3 weeks

Secondary Outcome Measures

Name	Time	Method
Mean pulmonary artery pressure in invasive monitoring	3weeks; 6 and 12 months after the procedure.	Patients will be installed catheter Swan-Ganz in the intensive care unit for invasive measurement of pulmonary artery pressure.
quality of life	3weeks; 6 and 12 months after the procedure.	SF-36 questionnaire
Exercise tolerance (the 6 minute walk test (6MWD)	3weeks; 6 and 12 months after the procedure.	the 6 minute walk test (6MWD)
adverse events	3 weeks	complications associated with the procedure plexus ganglion ablation, such as perforation of the pulmonary artery, pulmonary artery dissection, pulmonary embolism.

Trial Locations

Locations (1)

Novosibirsk State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation