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

Atrial Fibrillation Clinical Trial

— PADN+AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05856461
• Other study ID #: MEN_02052023
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: February 22, 2025

Study information

• Verified date: May 2023
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Alexander Romanov, MD
• Phone: +73833327655
• Email: abromanov[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: February 22, 2025
• Est. primary completion date: December 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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

Locations

Country	Name	City	State
Russian Federation	E. Meshalkin National Medical Research Center	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia	Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia 3 months after blanking period without antiarrhythmic drugs	12 months
Secondary	Perioperative complications	Perioperative complications, including Death, Stroke, TIA, myocardial infarction, cardiac tamponade, pulmonary vein stenosis, pulmonary vein stenosis, vascular complications	30 days
Secondary	Clinical adverse events	Death, Stroke, TIA, myocardial infarction, cardiac arrest, bleedings	12 months
Secondary	Number of hospitalizations	Hospitalizations due to atrial fibrillation of heart failure	12 months
Secondary	Mean pulmonary artery pressure	Changes in mean pulmonary artery pressure between groups	12 months
Secondary	Pulmonary vascular resistance	Changes in the pulmonary vascular resistance between groups	12 months
Secondary	Pulmonary wedge pressure	Changes in the pulmonary wedge pressure between groups	12 months
Secondary	Systolic pulmonary artery pressure	Changes in the systolic pulmonary artery pressure between groups	12 months
Secondary	6-minutes walking distance	Changes in the 6-minutes walking distance between groups	12 months
Secondary	Atrial fibrillation burden	Changes in the atrial fibrillation burden between groups	12 months
Secondary	Brain natriuretic peptide	Changes in the brain natriuretic peptide between groups	12 months