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Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

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ClinicalTrials.gov Identifier: NCT02745106
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Alexander Edemskiy, 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.

Condition or disease Intervention/treatment Phase
Chronic Thromboembolic Pulmonary Hypertension Procedure: Radiofrequency pulmonary artery denervation Device: Ablation catheter Device: Swan-Ganz catheter for right heart catheterization Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Pilot Trial of Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy
Study Start Date : August 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : February 2017


Arm Intervention/treatment
Experimental: PADN treatment

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
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.
Other Name: PADN
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)
Sham Comparator: Control (Sham)

Procedure: Right heart catheterization

Using following device:

- Swan-Ganz catheter

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)



Primary Outcome Measures :
  1. Pulmonary vascular resistance [ Time Frame: 12 months ]
    Units - (dyn x sec x cm-5)


Secondary Outcome Measures :
  1. 6-minute walking distance test [ Time Frame: 12 months ]
  2. Echocardiographical sings of right ventricle function - 1 [ Time Frame: 12 months ]
    Fractional area change (%)

  3. Echocardiographical sings of right ventricle function - 2 [ Time Frame: 12 months ]
    Tricuspid annular systolic excursion, TAPSE (mm)

  4. Pulmonary artery pressure [ Time Frame: 12 months ]
    Pulmonary artery pressure (systolic/diastolic/mean) will be measured by right heart catheterization



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02745106


Contacts
Contact: Alexander Edemskiy, MD +79139160665 aeskander@yandex.ru
Contact: Natalya Novikova, MD +79139497601 natnov@ngs.ru

Locations
Russian Federation
Novosibirsk research institute of circulation pathology Recruiting
Novosibirsk, Novosibirskaya oblast', Russian Federation, 630055
Contact: Alexander Edemskiy, MD    +79139160665    aeskander@yandex.ru   
Sponsors and Collaborators
Novosibirsk Scientific Research Institute for Circulatory Pathology
Investigators
Study Chair: Alexander Chernyavskiy, PhD 15 Rechkunovskaya street, Novosibirsk, Russia, 630055
Study Chair: Alexander Romanov, PhD Novosibirsk Scientific Research Institute for Circulatory Pathology
Study Chair: Evgeny Pokushalov, PhD Novosibirsk Scientific Research Institute for Circulatory Pathology

Responsible Party: Alexander Edemskiy, Principal investigator Alexander Edemskiy, Novosibirsk Scientific Research Institute for Circulatory Pathology
ClinicalTrials.gov Identifier: NCT02745106     History of Changes
Other Study ID Numbers: PADN1
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Alexander Edemskiy, Novosibirsk Scientific Research Institute for Circulatory Pathology:
Chronic thromboembolic pulmonary hypertension, Navigation system, Ablation

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases