Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

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

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)

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

Conditions
-----------------
Chronic Thromboembolic Pulmonary Hypertension

Intervention / Treatment
-----------------
* Procedure: Radiofrequency pulmonary artery denervation
* Device: Ablation catheter
* Device: Swan-Ganz catheter for right heart catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PADN treatment<br>Procedure/Surgery: Right heart catheterization, Radiofrequency pulmonary artery denervation using following devices: Ablation catheter Carto 3, Carto RMT, Stereotaxis Swan-Ganz catheter | Procedure: Radiofrequency pulmonary artery denervation<br>* 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.<br>* Other names: PADN;Device: Ablation catheter<br>* 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.<br>Device: Swan-Ganz catheter for right heart catheterization<br>* 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)<br>|
| Sham Comparator: Control (Sham)<br>Procedure: Right heart catheterization Using following device: - Swan-Ganz catheter | Device: Swan-Ganz catheter for right heart catheterization<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic thromboembolic pulmonary hypertension, Navigation system, Ablation