Atrial FibrillationPADN+AFNCT05856461
Pulmonary Artery Denervation in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension
A study testing Pulmonary vein isolation and Pulmonary artery denervation in people with Atrial Fibrillation and Pulmonary Hypertension, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
The goal of the study is to compare efficacy and safety of the pulmonary artery denervation procedure combined with atrial fibrillation ablation versus atrial fibrillation ablation alone in patients with paroxysmal and persistent atrial fibrillation and group 2 of the pulmonary hypertension Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Pulmonary Hypertension
- What is being tested?
- Pulmonary vein isolation and Pulmonary artery denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteRussia
- Study dates
- 22 May 2023to 22 Feb 2025
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mean pulmonary artery pressure > 25 mm Hg and pulmonary artery wedge pressure > 15 mm Hg by right heart catheterization
- Paroxysmal or persistent atrial fibrillation
- NYHA II-III
- BNP > 105 pg/ml
- Indications for catheter ablation of atrial fibrillation according guidelines
- LVEF > 50%
Who cannot join
- Group 1,3,4 of the pulmonary hypertension
- Left atrium diameter > 6 cm
- Planned open heart surgery procedure
- Previous heart valve surgery
- Severe aortic, pulmonary, tricuspid or mitral, valves regurgitation
- Thrombus in the left heart chambers
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
E. Meshalkin National Medical Research Center
Novosibirsk, 630055
Alexander B Romanov, MD, +73833327655, abromanov@mail.ru
Vitaly Shabanov, MD, +73833327655, v.v.shabanov@hotmail.com
About this study
Official title: Pulmonary Artery Denervation+ Atrial Fibrillation Ablation vs Atrial Fibrillation Ablation Only in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension
The goal of the study is to compare efficacy and safety of the pulmonary artery denervation procedure combined with atrial fibrillation ablation versus atrial fibrillation ablation alone in patients with paroxysmal and persistent atrial fibrillation and group 2 of the pulmonary hypertension
- Conditions
- Atrial Fibrillation, Pulmonary Hypertension
- Being tested
- Pulmonary vein isolation, Sham pulmonary artery denervation, Pulmonary artery denervation
- Keywords
- Atrial fibrillation, Pulmonary Hypertension, Remote magnetic navigation, Catheter ablation
- Medical subject headings
- Atrial Fibrillation, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolationProcedure or surgery
Circumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification
Sham pulmonary artery denervationProcedure or surgery
Sham pulmonary artery denervation procedure includes 3D reconstruction of the right ventricular outflow tract, main, left and right pulmonary arteries with creation of the false ablation points. No true ablation lesions will be performed in the pulmonary artery
Pulmonary artery denervationProcedure or surgery
Pulmonary artery denervation procedure includes 3D reconstruction of the right ventricular outflow tract, main, left and right pulmonary arteries and 3 circles of ablation lesions (bifurcation of the main pulmonary artery, left and right pulmonary arteries)
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary vein isolation+sham pulmonary artery denervation (group 1) | Sham comparator | In group 1, standard pulmonary vein isolation will be performed (with manual or remote robotic 3D navigation using radiofrequency energy) with sham pulmonary artery denervation procedure including 3D reconstruction of the pulmonary artery tree and creation of the false ablation point Receives: Procedure: Pulmonary vein isolation; Procedure: Sham pulmonary artery denervation |
| Pulmonary vein isolation+pulmonary artery denervation (group 2) | Active comparator | In group 2, standard pulmonary vein isolation will be performed (with manual or remote robotic 3D navigation using radiofrequency energy) combined with pulmonary artery denervation procedure Receives: Procedure: Pulmonary vein isolation; Procedure: Pulmonary artery denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia
Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia 3 months after blanking period without antiarrhythmic drugs
Measured: 12 months
Secondary outcomes (10)
Perioperative complications
Perioperative complications, including Death, Stroke, TIA, myocardial infarction, cardiac tamponade, pulmonary vein stenosis, pulmonary vein stenosis, vascular complications
Measured: 30 days
Clinical adverse events
Death, Stroke, TIA, myocardial infarction, cardiac arrest, bleedings
Measured: 12 months
Number of hospitalizations
Hospitalizations due to atrial fibrillation of heart failure
Measured: 12 months
Mean pulmonary artery pressure
Changes in mean pulmonary artery pressure between groups
Measured: 12 months
Pulmonary vascular resistance
Changes in the pulmonary vascular resistance between groups
Measured: 12 months
Pulmonary wedge pressure
Changes in the pulmonary wedge pressure between groups
Measured: 12 months
Systolic pulmonary artery pressure
Changes in the systolic pulmonary artery pressure between groups
Measured: 12 months
6-minutes walking distance
Changes in the 6-minutes walking distance between groups
Measured: 12 months
Atrial fibrillation burden
Changes in the atrial fibrillation burden between groups
Measured: 12 months
Brain natriuretic peptide
Changes in the brain natriuretic peptide between groups
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 posted12 May 2023
- Study start22 May 2023
- Primary completion29 Dec 2024 (estimated)
- Study completion22 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 parellel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Alexander B Romanov, MD, Principal investigator, E. Meshalkin National Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856461
- Sponsor's protocol ID
- MEN_02052023
- Acronym
- PADN+AF
- Status last verified
- May 2023
- First submitted
- 3 May 2023
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Artery Denervation+ Atrial Fibrillation Ablation vs Atrial Fibrillation Ablation Only in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT05856461
- Acronym / sponsor ID
- PADN+AF / MEN_02052023
- Conditions
- Atrial Fibrillation, Pulmonary Hypertension
- Keywords
- Atrial fibrillation, Pulmonary Hypertension, Remote magnetic navigation, Catheter ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 22 May 2023 (actual)
- Primary completion
- 29 Dec 2024 (estimated)
- Study completion
- 22 Feb 2025 (estimated)
- First posted
- 12 May 2023 (actual)
- 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 goal of the study is to compare efficacy and safety of the pulmonary artery denervation procedure combined with atrial fibrillation ablation versus atrial fibrillation ablation alone in patients with paroxysmal and persistent atrial fibrillation and group 2 of the pulmonary hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 parellel groups
| Arm | Type | Receives |
|---|---|---|
| Pulmonary vein isolation+sham pulmonary artery denervation (group 1) | Sham comparator | Procedure: Pulmonary vein isolation, Procedure: Sham pulmonary artery denervationIn group 1, standard pulmonary vein isolation will be performed (with manual or remote robotic 3D navigation using radiofrequency energy) with sham pulmonary artery denervation procedure including 3D reconstruction of the pulmonary artery tree and creation of the false ablation point |
| Pulmonary vein isolation+pulmonary artery denervation (group 2) | Active comparator | Procedure: Pulmonary vein isolation, Procedure: Pulmonary artery denervationIn group 2, standard pulmonary vein isolation will be performed (with manual or remote robotic 3D navigation using radiofrequency energy) combined with pulmonary artery denervation procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Mean pulmonary artery pressure > 25 mm Hg and pulmonary artery wedge pressure > 15 mm Hg by right heart catheterization
- Paroxysmal or persistent atrial fibrillation
- NYHA II-III
- BNP > 105 pg/ml
- Indications for catheter ablation of atrial fibrillation according guidelines
Key exclusion criteria (6 listed)
- Group 1,3,4 of the pulmonary hypertension
- Left atrium diameter > 6 cm
- Planned open heart surgery procedure
- Previous heart valve surgery
- Severe aortic, pulmonary, tricuspid or mitral, valves regurgitation
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 |
|---|---|---|
| Pulmonary vein isolationCircumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification | Procedure or surgery | Pulmonary vein isolation+pulmonary artery denervation (group 2), Pulmonary vein isolation+sham pulmonary artery denervation (group 1) |
| Sham pulmonary artery denervationSham pulmonary artery denervation procedure includes 3D reconstruction of the right ventricular outflow tract, main, left and right pulmonary arteries with creation of the false ablation points. No true ablation lesions will be performed in the pulmonary artery | Procedure or surgery | Pulmonary vein isolation+sham pulmonary artery denervation (group 1) |
| Pulmonary artery denervationPulmonary artery denervation procedure includes 3D reconstruction of the right ventricular outflow tract, main, left and right pulmonary arteries and 3 circles of ablation lesions (bifurcation of the main pulmonary artery, left and right pulmonary arteries) | Procedure or surgery | Pulmonary vein isolation+pulmonary artery denervation (group 2) |
Primary outcome
Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia
Time frame: 12 months
Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia 3 months after blanking period without antiarrhythmic drugs
10 secondary outcomes
Perioperative complications
Time frame: 30 days
Clinical adverse events
Time frame: 12 months
Number of hospitalizations
Time frame: 12 months
Mean pulmonary artery pressure
Time frame: 12 months
Pulmonary vascular resistance
Time frame: 12 months
Pulmonary wedge pressure
Time frame: 12 months
Systolic pulmonary artery pressure
Time frame: 12 months
6-minutes walking distance
Time frame: 12 months
Atrial fibrillation burden
Time frame: 12 months
Brain natriuretic peptide
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 25 May 2023.
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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 B Romanov, MD principal investigator
E. Meshalkin National Medical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein isolation and Pulmonary artery denervation in people with Atrial Fibrillation and Pulmonary Hypertension, run by Meshalkin Research Institute of Pathology of Circulation 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 6 inclusion and 6 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 25 May 2023. 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.
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 Romanov, MD (+73833327655, abromanov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia (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 25 May 2023.