Chronic Thromboembolic Pulmonary HypertensionPhase 2NCT02745106
Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy
A Phase 2 study testing Radiofrequency pulmonary artery denervation, Ablation catheter and Swan-Ganz catheter for right heart catheterization in people with Chronic Thromboembolic Pulmonary Hypertension, run by Novosibirsk Scientific Research Institute for Circulatory Pathology at 1 site in Russia.
Trial summary
The study evaluates the technique of non-drug treatment of residual pulmonary hypertension in patients with chronic thromboembolic pulmonary hypertension after pulmonary thromboendarterectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Radiofrequency pulmonary artery denervation, Ablation catheter and Swan-Ganz catheter for right heart catheterization
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- Aug 2015to Feb 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Novosibirsk research institute of circulation pathology
Novosibirsk, Novosibirsk Oblast, 630055
Alexander Edemskiy, MD, +79139160665, aeskander@yandex.ru
About this study
Official title: Randomized Pilot Trial of Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy
The study evaluates the technique of non-drug treatment of residual pulmonary hypertension in patients with chronic thromboembolic pulmonary hypertension after pulmonary thromboendarterectomy.
Read the 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)
- Being tested
- Radiofrequency pulmonary artery denervation, Ablation catheter, Swan-Ganz catheter for right heart catheterization
- Keywords
- Chronic thromboembolic pulmonary hypertension, Navigation system, Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency pulmonary artery denervationProcedure or surgery
Also called PADN
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.
Ablation catheterDevice
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.
Swan-Ganz catheter for right heart catheterizationDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Swan-Ganz catheter for right heart catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary vascular resistance
Units - (dyn x sec x cm-5)
Measured: 12 months
Secondary outcomes (4)
6-minute walking distance test
Measured: 12 months
Echocardiographical sings of right ventricle function - 1
Fractional area change (%)
Measured: 12 months
Echocardiographical sings of right ventricle function - 2
Tricuspid annular systolic excursion, TAPSE (mm)
Measured: 12 months
Pulmonary artery pressure
Pulmonary artery pressure (systolic/diastolic/mean) will be measured by right heart catheterization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startAug 2015
- Primary completionDec 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novosibirsk Scientific Research Institute for Circulatory Pathology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Edemskiy, Novosibirsk Scientific Research Institute for Circulatory Pathology
- Investigators
- Alexander Chernyavskiy, PhD, Study chair, 15 Rechkunovskaya street, Novosibirsk, Russia, 630055Alexander Romanov, PhD, Study chair, Novosibirsk Scientific Research Institute for Circulatory PathologyEvgeny Pokushalov, PhD, Study chair, Novosibirsk Scientific Research Institute for Circulatory Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745106
- Sponsor's protocol ID
- PADN1
- Status last verified
- Jun 2016
- First submitted
- 4 Apr 2016
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Trial of Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy
- ClinicalTrials.gov ID
- NCT02745106
- Acronym / sponsor ID
- PADN1
- Keywords
- Chronic thromboembolic pulmonary hypertension, Navigation system, Ablation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Novosibirsk Scientific Research Institute for Circulatory PathologyUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PADN treatment | Experimental | Procedure: Radiofrequency pulmonary artery denervation, Device: Ablation catheter, Device: Swan-Ganz catheter for right heart catheterizationProcedure/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) | Sham comparator | Device: Swan-Ganz catheter for right heart catheterizationProcedure: Right heart catheterization Using following device: - Swan-Ganz catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency pulmonary artery denervationAlso: PADNRadiofrequency 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. | Procedure or surgery | PADN treatment |
| Ablation catheter4MM 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 | PADN treatment |
| Swan-Ganz catheter for right heart catheterizationStandart 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) | Device | Control (Sham), PADN treatment |
Primary outcome
Pulmonary vascular resistance
Time frame: 12 months
Units - (dyn x sec x cm-5)
4 secondary outcomes
6-minute walking distance test
Time frame: 12 months
Echocardiographical sings of right ventricle function - 1
Time frame: 12 months
Echocardiographical sings of right ventricle function - 2
Time frame: 12 months
Pulmonary artery pressure
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Chernyavskiy, PhD study chair
15 Rechkunovskaya street, Novosibirsk, Russia, 630055
Alexander Romanov, PhD study chair
Novosibirsk Scientific Research Institute for Circulatory Pathology
Evgeny Pokushalov, PhD study chair
Novosibirsk Scientific Research Institute for Circulatory Pathology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiofrequency pulmonary artery denervation, Ablation catheter and Swan-Ganz catheter for right heart catheterization in people with Chronic Thromboembolic Pulmonary Hypertension, run by Novosibirsk Scientific Research Institute for Circulatory Pathology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Edemskiy, MD (+79139160665, aeskander@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary vascular resistance (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2016; AzTrials last refreshed its copy on 8 Nov 2026.