Pulmonary Artery Denervation in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension (PADN+AF)

May 24, 2023 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Pulmonary vein isolation+sham pulmonary artery denervation (group 1)
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
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
Active Comparator: Pulmonary vein isolation+pulmonary artery denervation (group 2)
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
Procedure: Pulmonary vein isolation
Circumferential pulmonary vein isolation procedure using 3D navigation systems with entrance and exit block verification
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Investigators

  • Principal Investigator: Alexander B Romanov, MD, E. Meshalkin National Medical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2023

Primary Completion (Estimated)

December 29, 2024

Study Completion (Estimated)

February 22, 2025

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEN_02052023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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