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

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ClinicalTrials.gov Identifier: NCT02374229
Recruitment Status : Unknown
Verified September 2015 by Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Recruiting
First Posted : February 27, 2015
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Procedure: Surgical ablation of ganglion plexus pulmonary artery. Procedure: mitral valve surgery Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.
Study Start Date : February 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

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.
Other Names:
  • surgical ablation
  • radiofrequency ablation

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.
Other Names:
  • mitral valve repair
  • mitral velve replacement

Active Comparator: 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.

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.
Other Names:
  • mitral valve repair
  • mitral velve replacement




Primary Outcome Measures :
  1. Death of the patient [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Mean pulmonary artery pressure in invasive monitoring [ Time Frame: 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.

  2. Exercise tolerance (the 6 minute walk test (6MWD) [ Time Frame: 3weeks; 6 and 12 months after the procedure. ]
    the 6 minute walk test (6MWD)

  3. quality of life [ Time Frame: 3weeks; 6 and 12 months after the procedure. ]
    SF-36 questionnaire

  4. adverse events [ Time Frame: 3 weeks ]
    complications associated with the procedure plexus ganglion ablation, such as perforation of the pulmonary artery, pulmonary artery dissection, pulmonary embolism.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374229


Contacts
Contact: Aleksandr V Bogachev-Prokophiev, MD PhD +79137539546 bogachev.prokophiev@gmail.com

Locations
Russian Federation
Novosibirsk State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Alexander V Bogachev-Prokophiev, MD PhD    +79137539546    bogachev.prokophiev@gmail.com   
Contact: Denis P Demidov    +79231935938    demidoff85@mail.ru   
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: Aleksandr V Bogachev-Prokophiev, MD PhD Meshalkin Research Institute of Pathology of Circulation

Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02374229     History of Changes
Other Study ID Numbers: GAPA 1
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
pulmonary hypertension
pulmonary artery denervation
mitral valve disease

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases