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

NCT05856461 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2023-05-25

No results posted yet for this study

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

Conditions

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)

Sponsors & Collaborators

  • Meshalkin Research Institute of Pathology of Circulation

    lead NETWORK

Principal Investigators

  • Alexander B Romanov, MD · E. Meshalkin National Medical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-22
Primary Completion
2024-12-29
Completion
2025-02-22

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05856461 on ClinicalTrials.gov