NCT02745106

Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Novosibirsk Scientific Research Institute for Circulatory Pathology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Chronic Thromboembolic Pulmonary Hypertension

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-12-01
• Completion: 2017-02-01
• First posted: 2016-04-20
• Last updated: 2016-06-03

Locations

1 site across 1 country: Russia