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

NCT05856461 — Not applicable, Unknown, 116 participants, Meshalkin Research Institute of Pathology of Circulation

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Pulmonary Artery Denervation+ Atrial Fibrillation Ablation vs Atrial Fibrillation Ablation Only in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension

Registry	NCT05856461, acronym PADN+AF
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	116 (Estimated)
Sponsor	Meshalkin Research Institute of Pathology of Circulation (Network)
Conditions	Atrial Fibrillation, Pulmonary Hypertension
Interventions	Pulmonary vein isolation, Sham pulmonary artery denervation, Pulmonary artery denervation (Procedure)
Dates	start 2023-05-22, primary completion 2024-12-29 (estimated), completion 2025-02-22 (estimated), first posted 2023-05-12, last updated 2023-05-25
Locations	1 site in Russia

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Pulmonary vein isolation+sham pulmonary artery denervation (group 1)	Sham comparator	Procedure: Pulmonary vein isolation; Procedure: Sham pulmonary artery denervation	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
Pulmonary vein isolation+pulmonary artery denervation (group 2)	Active comparator	Procedure: Pulmonary vein isolation; Procedure: Pulmonary artery denervation	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

Pulmonary vein isolation (Procedure): Circumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification
Sham pulmonary artery denervation (Procedure): 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 denervation (Procedure): 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)

+Outcome measures

Primary outcomes

Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia [12 months]: Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia 3 months after blanking period without antiarrhythmic drugs

Secondary outcomes

Perioperative complications [30 days]: Perioperative complications, including Death, Stroke, TIA, myocardial infarction, cardiac tamponade, pulmonary vein stenosis, pulmonary vein stenosis, vascular complications
Clinical adverse events [12 months]: Death, Stroke, TIA, myocardial infarction, cardiac arrest, bleedings
Number of hospitalizations [12 months]: Hospitalizations due to atrial fibrillation of heart failure
Mean pulmonary artery pressure [12 months]: Changes in mean pulmonary artery pressure between groups
Pulmonary vascular resistance [12 months]: Changes in the pulmonary vascular resistance between groups
Pulmonary wedge pressure [12 months]: Changes in the pulmonary wedge pressure between groups
Systolic pulmonary artery pressure [12 months]: Changes in the systolic pulmonary artery pressure between groups
6-minutes walking distance [12 months]: Changes in the 6-minutes walking distance between groups
Atrial fibrillation burden [12 months]: Changes in the atrial fibrillation burden between groups
Brain natriuretic peptide [12 months]: Changes in the brain natriuretic peptide between groups

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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

+Locations (1)

Facility	City	Country	Status
E. Meshalkin National Medical Research Center	Novosibirsk	Russia	Recruiting

+Investigators

Alexander B Romanov, MD, Principal investigator, E. Meshalkin National Medical Research Center

My Notes

Public

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