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Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

Primary Purpose

Chronic Thromboembolic Pulmonary Hypertension

Status

Unknown status

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

Radiofrequency pulmonary artery denervation

Ablation catheter

Swan-Ganz catheter for right heart catheterization

About this trial

This is an interventional treatment trial for Chronic Thromboembolic Pulmonary Hypertension focused on measuring Chronic thromboembolic pulmonary hypertension, Navigation system, Ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Novosibirsk research institute of circulation pathologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

PADN treatment

Control (Sham)

Arm Description

Procedure/Surgery: Right heart catheterization, Radiofrequency pulmonary artery denervation using following devices: Ablation catheter Carto 3, Carto RMT, Stereotaxis Swan-Ganz catheter

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

Outcomes

Primary Outcome Measures

Pulmonary vascular resistance

Units - (dyn x sec x cm-5)

Secondary Outcome Measures

6-minute walking distance test

Echocardiographical sings of right ventricle function - 1

Fractional area change (%)

Echocardiographical sings of right ventricle function - 2

Tricuspid annular systolic excursion, TAPSE (mm)

Pulmonary artery pressure

Pulmonary artery pressure (systolic/diastolic/mean) will be measured by right heart catheterization

Full Information

NCT ID

NCT02745106

First Posted

April 4, 2016

Last Updated

June 1, 2016

Sponsor

Novosibirsk Scientific Research Institute for Circulatory Pathology

1. Study Identification

Unique Protocol Identification Number

NCT02745106

Brief Title

Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

Official Title

Randomized Pilot Trial of Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Novosibirsk Scientific Research Institute for Circulatory Pathology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Thromboembolic Pulmonary Hypertension

Keywords

Chronic thromboembolic pulmonary hypertension, Navigation system, Ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PADN treatment

Arm Type

Experimental

Arm Description

Procedure/Surgery: Right heart catheterization, Radiofrequency pulmonary artery denervation using following devices: Ablation catheter Carto 3, Carto RMT, Stereotaxis Swan-Ganz catheter

Arm Title

Control (Sham)

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Radiofrequency pulmonary artery denervation

Other Intervention Name(s)

PADN

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Ablation catheter

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Swan-Ganz catheter for right heart catheterization

Intervention Description

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 Measure Information:

Title

Pulmonary vascular resistance

Description

Units - (dyn x sec x cm-5)

Time Frame

12 months

Secondary Outcome Measure Information:

Title

6-minute walking distance test

Time Frame

12 months

Title

Echocardiographical sings of right ventricle function - 1

Description

Fractional area change (%)

Time Frame

12 months

Title

Echocardiographical sings of right ventricle function - 2

Description

Tricuspid annular systolic excursion, TAPSE (mm)

Time Frame

12 months

Title

Pulmonary artery pressure

Description

Pulmonary artery pressure (systolic/diastolic/mean) will be measured by right heart catheterization

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexander Edemskiy, MD

Phone

+79139160665

aeskander@yandex.ru

First Name & Middle Initial & Last Name or Official Title & Degree

Natalya Novikova, MD

Phone

+79139497601

natnov@ngs.ru

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander Chernyavskiy, PhD

Organizational Affiliation

15 Rechkunovskaya street, Novosibirsk, Russia, 630055

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Alexander Romanov, PhD

Organizational Affiliation

Novosibirsk Scientific Research Institute for Circulatory Pathology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Evgeny Pokushalov, PhD

Organizational Affiliation

Novosibirsk Scientific Research Institute for Circulatory Pathology

Official's Role

Study Chair

Facility Information:

Facility Name

Novosibirsk research institute of circulation pathology

City

Novosibirsk

State/Province

Novosibirskaya oblast'

ZIP/Postal Code

630055

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexander Edemskiy, MD

Phone

+79139160665

aeskander@yandex.ru

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

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