Pulmonary Artery Denervation in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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%
Exclusion Criteria:
- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05856461
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Meshalkin Research Institute of Pathology of Circulation
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alexander B Romanov, MD
Principal Investigator Affiliation	E. Meshalkin National Medical Research Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Russian Federation
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Atrial Fibrillation, Pulmonary Hypertension

Arms & Interventions

Arms

Sham Comparator: Pulmonary vein isolation+sham pulmonary artery denervation (group 1)

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

Active Comparator: Pulmonary vein isolation+pulmonary artery denervation (group 2)

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

Interventions

Procedure: - Pulmonary vein isolation

Circumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification

Procedure: - Sham pulmonary artery denervation

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

Procedure: - Pulmonary artery denervation

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)

Contact a Trial Team

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