NCT05856461
Recruiting
Not Applicable
Pulmonary Artery Denervation+ Atrial Fibrillation Ablation vs Atrial Fibrillation Ablation Only in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension
Meshalkin Research Institute of Pathology of Circulation1 site in 1 country116 target enrollmentMay 22, 2023
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Number of hospitalizations(12 months)
- Perioperative complications(30 days)
- Pulmonary vascular resistance(12 months)
- Pulmonary wedge pressure(12 months)
- Clinical adverse events(12 months)
- Mean pulmonary artery pressure(12 months)
- Systolic pulmonary artery pressure(12 months)
- 6-minutes walking distance(12 months)
- Atrial fibrillation burden(12 months)
- Brain natriuretic peptide(12 months)
Study Sites (1)
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