Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

Summary

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

Conditions

• Chronic Thromboembolic Pulmonary Hypertension

Interventions

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.

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)

Sponsors & Collaborators

• Novosibirsk Scientific Research Institute for Circulatory Pathology

  lead OTHER

Principal Investigators

• Alexander Chernyavskiy, PhD · 15 Rechkunovskaya street, Novosibirsk, Russia, 630055

• Alexander Romanov, PhD · Novosibirsk Scientific Research Institute for Circulatory Pathology

• Evgeny Pokushalov, PhD · Novosibirsk Scientific Research Institute for Circulatory Pathology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2016-12-31

Completion

2017-02-28

Countries

• Russia

Study Locations