Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

June 1, 2016 updated by: Alexander Edemskiy, Novosibirsk Scientific Research Institute for Circulatory Pathology

Randomized Pilot Trial of Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

The study evaluates the technique of non-drug treatment of residual pulmonary hypertension in patients with chronic thromboembolic pulmonary hypertension after pulmonary thromboendarterectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The best strategy of treatment patients with chronic thromboembolic pulmonary hypertension is pulmonary thromboendarterectomy. In 5-30% of cases after pulmonary thromboendarterectomy residual pulmonary hypertension is persisted. The technique of radiofrequency pulmonary artery denervation in patients with idiopathic pulmonary arterial hypertension (type I) is known and was assessed during clinical investigation. In this study radiofrequency pulmonary artery denervation technique may be applied in patients with residual pulmonary hypertension after pulmonary thromboendarterectomy (type IV)

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Novosibirskaya oblast'
      • Novosibirsk, Novosibirskaya oblast', Russian Federation, 630055
        • Recruiting
        • Novosibirsk Research Institute of Circulation Pathology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of residual pulmonary hypertension in patients after pulmonary thromboendarterectomy according to right heart catheterization: mean pulmonary artery pressure > 25 mm Hg or pulmonary vascular resistance > 400 dyn x sec x cm-5

Exclusion Criteria:

  • no evidence of residual pulmonary hypertension in patients after pulmonary thromboendarterectomy (mean pulmonary artery pressure <25 m Hg).
  • refusal of a patient to participate in the study.
  • the presence of severe concomitant diseases of the cardiovascular system and lungs, leading to pulmonary hypertension
  • the presence of other severe comorbidities that may result in death within a year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PADN treatment

Procedure/Surgery: Right heart catheterization, Radiofrequency pulmonary artery denervation using following devices:

  1. Ablation catheter
  2. Carto 3, Carto RMT, Stereotaxis
  3. Swan-Ganz catheter
Procedure: Radiofrequency pulmonary artery denervation
Radiofrequency ablation of pulmonary artery will be performed with standard electrophysiological catheter and non-fluoroscopic 3D-navigation system. Right heart catheterization (thermodilution method with Swan-Ganz catheter) will be performed before and after procedure. The radiofrequent impact will be performed 2mm after pulmonary artery bifurcation in both right and left main pulmonary artery branches. The radiofrequent impact will be performed at temperature 40-42 C, up to 12 watts and 60 second duration in every ablation point under impedance control.
Other Names:
  • PADN
Device: Ablation catheter
4MM RF CONDUCTR (MULTI-CURVE) SERIES ABLATION CATHETER Standart procedure for radiofrequency ablation: Radiofrequency ablation of pulmonary artery will be performed with standard electrophysiological catheter and non-fluoroscopic 3D-navigation system. Right heart catheterization (thermodilution method with Swan-Ganz catheter) will be performed before and after procedure. The radiofrequent impact will be performed 2mm after pulmonary artery bifurcation in both right and left main pulmonary artery branches. The radiofrequent impact will be performed at temperature 40-42 C, up to 12 watts and 60 second duration in every ablation point under impedance control.
Device: Swan-Ganz catheter for right heart catheterization

Standart procedure of right catheterization:

  • punction of right jugular vein with Seldinger technique, introducer placement
  • insertion of Swan-Ganz catheter via introducer in jugular vein under fluoroscopic control and wave form of monitor's curve.
  • positioning of swan-ganz catheter in pulmonary artery
  • direct central hemodynamics measurements: systolic/diastolic/mean pulmonary artery pressure, pulmonary capillary wedge pressure, cardiac output (thermodilution technique)
  • calculating of indirect parameters (pulmonary vascular resistance)
Sham Comparator: Control (Sham)

Procedure: Right heart catheterization

Using following device:

- Swan-Ganz catheter
Device: Swan-Ganz catheter for right heart catheterization

Standart procedure of right catheterization:

  • punction of right jugular vein with Seldinger technique, introducer placement
  • insertion of Swan-Ganz catheter via introducer in jugular vein under fluoroscopic control and wave form of monitor's curve.
  • positioning of swan-ganz catheter in pulmonary artery
  • direct central hemodynamics measurements: systolic/diastolic/mean pulmonary artery pressure, pulmonary capillary wedge pressure, cardiac output (thermodilution technique)
  • calculating of indirect parameters (pulmonary vascular resistance)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary vascular resistance
Time Frame: 12 months
Units - (dyn x sec x cm-5)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-minute walking distance test
Time Frame: 12 months
12 months
Echocardiographical sings of right ventricle function - 1
Time Frame: 12 months
Fractional area change (%)
12 months
Echocardiographical sings of right ventricle function - 2
Time Frame: 12 months
Tricuspid annular systolic excursion, TAPSE (mm)
12 months
Pulmonary artery pressure
Time Frame: 12 months
Pulmonary artery pressure (systolic/diastolic/mean) will be measured by right heart catheterization
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novosibirsk Scientific Research Institute for Circulatory Pathology

Investigators

  • Study Chair: Alexander Chernyavskiy, PhD, 15 Rechkunovskaya street, Novosibirsk, Russia, 630055
  • Study Chair: Alexander Romanov, PhD, Novosibirsk Scientific Research Institute for Circulatory Pathology
  • Study Chair: Evgeny Pokushalov, PhD, Novosibirsk Scientific Research Institute for Circulatory Pathology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

June 1, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PADN1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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