Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

NCT02745106 | Unknown Phase 2 DMC

• 1 other identifier: PADN1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Keywords

Chronic thromboembolic pulmonary hypertension, Navigation system, Ablation

Outcome Measures

Primary Outcomes (1)

• Pulmonary vascular resistance

  Units - (dyn x sec x cm-5)

  12 months

Secondary Outcomes (4)

• 6-minute walking distance test

  12 months

• Echocardiographical sings of right ventricle function - 1

  12 months

• Echocardiographical sings of right ventricle function - 2

  12 months

• Pulmonary artery pressure

  12 months

Study Arms (2)

PADN treatment

EXPERIMENTAL

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; Device: Ablation catheter; Device: Swan-Ganz catheter for right heart catheterization

Control (Sham)

SHAM COMPARATOR

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

Device: Swan-Ganz catheter for right heart catheterization

Interventions

Radiofrequency pulmonary artery denervation PROCEDURE

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.

Also known as: PADN

PADN treatment

Ablation catheter DEVICE

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.

PADN treatment

Swan-Ganz catheter for right heart catheterization DEVICE

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)

Control (Sham); PADN treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novosibirsk Scientific Research Institute for Circulatory Pathology: lead

Study Sites (1)

Novosibirsk research institute of circulation pathology

Novosibirsk, Novosibirsk Oblast, 630055, Russia

RECRUITING

MeSH Terms

Interventions

Catheter Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• 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

  STUDY CHAIR

Central Study Contacts

Alexander Edemskiy, MD

CONTACT

+79139160665; aeskander@yandex.ru

Natalya Novikova, MD

CONTACT

+79139497601; natnov@ngs.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator Alexander Edemskiy

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 20, 2016
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: June 3, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)