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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02374229
• Other study ID #: GAPA 1
• Status: Recruiting
• Phase: Phase 1
• First received: February 12, 2015
• Last updated: September 21, 2015
• Start date: February 2015
• Est. completion date: November 2016

Study information

• Verified date: September 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Aleksandr V Bogachev-Prokophiev, MD PhD
• Phone: +79137539546
• Email: bogachev.prokophiev[@]gmail.com
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	Novosibirsk State Research Institute of Circulation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death of the patient		3 weeks	Yes
Secondary	Mean pulmonary artery pressure in invasive monitoring	Patients will be installed catheter Swan-Ganz in the intensive care unit for invasive measurement of pulmonary artery pressure.	3weeks; 6 and 12 months after the procedure.	No
Secondary	Exercise tolerance (the 6 minute walk test (6MWD)	the 6 minute walk test (6MWD)	3weeks; 6 and 12 months after the procedure.	No
Secondary	quality of life	SF-36 questionnaire	3weeks; 6 and 12 months after the procedure.	No
Secondary	adverse events	complications associated with the procedure plexus ganglion ablation, such as perforation of the pulmonary artery, pulmonary artery dissection, pulmonary embolism.	3 weeks	Yes