Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-02-28

Brief Summary

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

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Detailed Description

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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)

Conditions

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Chronic Thromboembolic Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Radiofrequency pulmonary artery denervation

Intervention Type PROCEDURE

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.

Ablation catheter

Intervention Type DEVICE

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.

Swan-Ganz catheter for right heart catheterization

Intervention Type DEVICE

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)

Control (Sham)

Procedure: Right heart catheterization

Using following device:

\- Swan-Ganz catheter

Group Type SHAM_COMPARATOR

Swan-Ganz catheter for right heart catheterization

Intervention Type DEVICE

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)

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type 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)

Intervention Type DEVICE

Other Intervention Names

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PADN

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No