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

Primary Purpose

Pulmonary Hypertension

Status
Unknown status
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Surgical ablation of ganglion plexus pulmonary artery.
mitral valve surgery
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring pulmonary hypertension, pulmonary artery denervation, mitral valve disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novosibirsk State Research Institute of Circulation PathologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The study group

The control group

Arm Description

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: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.

Outcomes

Primary Outcome Measures

Death of the patient

Secondary Outcome Measures

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.
Exercise tolerance (the 6 minute walk test (6MWD)
the 6 minute walk test (6MWD)
quality of life
SF-36 questionnaire
adverse events
complications associated with the procedure plexus ganglion ablation, such as perforation of the pulmonary artery, pulmonary artery dissection, pulmonary embolism.

Full Information

First Posted
February 12, 2015
Last Updated
September 21, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02374229
Brief Title
Ablation of the Pulmonary Artery With High Pulmonary Hypertension During Mitral Valve Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
pulmonary hypertension, pulmonary artery denervation, mitral valve disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The study group
Arm Type
Experimental
Arm Description
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.
Arm Title
The control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgical ablation of ganglion plexus pulmonary artery.
Other Intervention Name(s)
surgical ablation, radiofrequency ablation
Intervention Description
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
Intervention Name(s)
mitral valve surgery
Other Intervention Name(s)
mitral valve repair, mitral velve replacement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Death of the patient
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Mean pulmonary artery pressure in invasive monitoring
Description
Patients will be installed catheter Swan-Ganz in the intensive care unit for invasive measurement of pulmonary artery pressure.
Time Frame
3weeks; 6 and 12 months after the procedure.
Title
Exercise tolerance (the 6 minute walk test (6MWD)
Description
the 6 minute walk test (6MWD)
Time Frame
3weeks; 6 and 12 months after the procedure.
Title
quality of life
Description
SF-36 questionnaire
Time Frame
3weeks; 6 and 12 months after the procedure.
Title
adverse events
Description
complications associated with the procedure plexus ganglion ablation, such as perforation of the pulmonary artery, pulmonary artery dissection, pulmonary embolism.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksandr V Bogachev-Prokophiev, MD PhD
Phone
+79137539546
Email
bogachev.prokophiev@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandr V Bogachev-Prokophiev, MD PhD
Organizational Affiliation
Meshalkin Research Institute of Pathology of Circulation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novosibirsk State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander V Bogachev-Prokophiev, MD PhD
Phone
+79137539546
Email
bogachev.prokophiev@gmail.com
First Name & Middle Initial & Last Name & Degree
Denis P Demidov
Phone
+79231935938
Email
demidoff85@mail.ru

12. IPD Sharing Statement

Learn more about this trial

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

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