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

Meshalkin Research Institute of Pathology of Circulation116 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

116

Conditions

Atrial Fibrillation Pulmonary Hypertension

Interventions

Pulmonary vein isolationPROCEDURE

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

Sham pulmonary artery denervationPROCEDURE

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

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

E. Meshalkin National Medical Research Center

Novosibirsk, Russia

RECRUITING

Outcomes

Primary Outcomes

Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia

Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia 3 months after blanking period without antiarrhythmic drugs

Time frame: 12 months

Secondary Outcomes

Perioperative complications

Perioperative complications, including Death, Stroke, TIA, myocardial infarction, cardiac tamponade, pulmonary vein stenosis, pulmonary vein stenosis, vascular complications

Time frame: 30 days

Clinical adverse events

Death, Stroke, TIA, myocardial infarction, cardiac arrest, bleedings

Time frame: 12 months

Number of hospitalizations

Hospitalizations due to atrial fibrillation of heart failure

Time frame: 12 months

Mean pulmonary artery pressure

Changes in mean pulmonary artery pressure between groups

Time frame: 12 months

Pulmonary vascular resistance

Changes in the pulmonary vascular resistance between groups

Time frame: 12 months

Pulmonary wedge pressure

Changes in the pulmonary wedge pressure between groups

Time frame: 12 months

Systolic pulmonary artery pressure

Changes in the systolic pulmonary artery pressure between groups

Time frame: 12 months

Central Contacts

Alexander Romanov, MD

CONTACT

+73833327655 abromanov@mail.ru

Vitaly Shabanov, MD

CONTACT

+73833327655 v.v.shabanov@hotmail.com

Data from ClinicalTrials.gov

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