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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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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

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Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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The study group

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.

Group Type EXPERIMENTAL

Surgical ablation of ganglion plexus pulmonary artery.

Intervention Type PROCEDURE

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.

mitral valve surgery

Intervention Type PROCEDURE

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.

The control group

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.

Group Type ACTIVE_COMPARATOR

mitral valve surgery

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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surgical ablation radiofrequency ablation mitral valve repair mitral velve replacement

Eligibility Criteria

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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.