Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study evaluates the technique of non-drug treatment of residual pulmonary hypertension in patients with chronic thromboembolic pulmonary hypertension after pulmonary thromboendarterectomy.
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)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PADN treatment | Experimental | Procedure/Surgery: Right heart catheterization, Radiofrequency pulmonary artery denervation using following devices:
|
|
| Control (Sham) | Sham Comparator | Procedure: Right heart catheterization Using following device: - Swan-Ganz catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency pulmonary artery denervation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary vascular resistance | Units - (dyn x sec x cm-5) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walking distance test | 12 months | |
| Echocardiographical sings of right ventricle function - 1 | Fractional area change (%) | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Edemskiy, MD | Contact | +79139160665 | aeskander@yandex.ru | |
| Natalya Novikova, MD | Contact | +79139497601 | natnov@ngs.ru |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Chernyavskiy, PhD | 15 Rechkunovskaya street, Novosibirsk, Russia, 630055 | Study Chair |
| Alexander Romanov, PhD | Novosibirsk Scientific Research Institute for Circulatory Pathology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novosibirsk research institute of circulation pathology | Recruiting | Novosibirsk | Novosibirsk Oblast | 630055 | Russia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Ablation catheter | 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 | Device | Standart procedure of right catheterization:
|
|
| 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 |
| Evgeny Pokushalov, PhD | Novosibirsk Scientific Research Institute for Circulatory Pathology | Study Chair |
| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided