Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

Phase 2

• Conditions: Chronic Thromboembolic Pulmonary Hypertension
• Interventions: Procedure: Radiofrequency pulmonary artery denervation; Device: Ablation catheter; Device: Swan-Ganz catheter for right heart catheterization

• Registration Number: NCT02745106
• Lead Sponsor: Novosibirsk Scientific Research Institute for Circulatory Pathology

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)

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-04-04
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-20
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-01
• Last Update Posted: 2016-06-03
• Primary Completion: 2016-12
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PADN treatment	Swan-Ganz catheter for right heart catheterization	Procedure/Surgery: Right heart catheterization, Radiofrequency pulmonary artery denervation using following devices: 1. Ablation catheter 2. Carto 3, Carto RMT, Stereotaxis 3. Swan-Ganz catheter
PADN treatment	Radiofrequency pulmonary artery denervation	Procedure/Surgery: Right heart catheterization, Radiofrequency pulmonary artery denervation using following devices: 1. Ablation catheter 2. Carto 3, Carto RMT, Stereotaxis 3. Swan-Ganz catheter
PADN treatment	Ablation catheter	Procedure/Surgery: Right heart catheterization, Radiofrequency pulmonary artery denervation using following devices: 1. Ablation catheter 2. Carto 3, Carto RMT, Stereotaxis 3. Swan-Ganz catheter
Control (Sham)	Swan-Ganz catheter for right heart catheterization	Procedure: Right heart catheterization Using following device: - Swan-Ganz catheter

Primary Outcome Measures

Name	Time	Method
Pulmonary vascular resistance	12 months	Units - (dyn x sec x cm-5)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novosibirsk research institute of circulation pathology; 🇷🇺 Novosibirsk, Novosibirskaya oblast', Russian Federation