Chronic Thromboembolic Pulmonary Hypertension
Conditions
Keywords
Chronic thromboembolic pulmonary hypertension, Navigation system, Ablation
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)
Interventions
PROCEDURERadiofrequency 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.
DEVICEAblation 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.
DEVICESwan-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
Novosibirsk Scientific Research Institute for Circulatory Pathology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary vascular resistance | 12 months | Units - (dyn x sec x cm-5) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walking distance test | 12 months | — |
| Echocardiographical sings of right ventricle function - 1 | 12 months | Fractional area change (%) |
| Echocardiographical sings of right ventricle function - 2 | 12 months | Tricuspid annular systolic excursion, TAPSE (mm) |
| Pulmonary artery pressure | 12 months | Pulmonary artery pressure (systolic/diastolic/mean) will be measured by right heart catheterization |
Countries
Russia
Contacts
Primary ContactAlexander Edemskiy, MD
Backup ContactNatalya Novikova, MD
Outcome results
None listed