NCT02374229

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

February 12, 2015

Last Update Submit

September 21, 2015

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertensionpulmonary artery denervationmitral valve disease

Outcome Measures

Primary Outcomes (1)

  • Death of the patient

    3 weeks

Secondary Outcomes (4)

  • Mean pulmonary artery pressure in invasive monitoring

    3weeks; 6 and 12 months after the procedure.

  • Exercise tolerance (the 6 minute walk test (6MWD)

    3weeks; 6 and 12 months after the procedure.

  • quality of life

    3weeks; 6 and 12 months after the procedure.

  • adverse events

    3 weeks

Study Arms (2)

The study group

EXPERIMENTAL

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.Procedure: mitral valve surgery

The control group

ACTIVE COMPARATOR

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

Interventions

Surgical ablation of ganglion plexus pulmonary artery.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.

Also known as: surgical ablation, radiofrequency ablation
The study group
mitral valve surgeryPROCEDURE

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.

Also known as: mitral valve repair, mitral velve replacement
The control groupThe study group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novosibirsk State Research Institute of Circulation Pathology

Novosibirsk, Novosibirsk Oblast, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Radiofrequency AblationMitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeCardiac Valve AnnuloplastyCardiac Surgical ProceduresCardiovascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Aleksandr V Bogachev-Prokophiev, MD PhD

    Meshalkin Research Institute of Pathology of Circulation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandr V Bogachev-Prokophiev, MD PhD

CONTACT

+79137539546bogachev.prokophiev@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2015

First Posted

February 27, 2015

Study Start

February 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

RU(1)