Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

Novosibirsk Scientific Research Institute for Circulatory Pathology

Status and phase: Unknown; Phase 2

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Treatments: Device: Ablation catheter; Device: Swan-Ganz catheter for right heart catheterization; Procedure: Radiofrequency pulmonary artery denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT02745106

PADN1

Details and patient eligibility

About

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

Full 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)

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

PADN treatment

Experimental group

Description:

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

Treatment:

Procedure: Radiofrequency pulmonary artery denervation

Device: Swan-Ganz catheter for right heart catheterization

Device: Ablation catheter

Control (Sham)

Sham Comparator group

Description:

Procedure: Right heart catheterization Using following device: - Swan-Ganz catheter

Treatment:

Device: Swan-Ganz catheter for right heart catheterization