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

Primary Purpose

Atrial Fibrillation, Pulmonary Hypertension

Status

Recruiting

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

Pulmonary vein isolation

Sham pulmonary artery denervation

Pulmonary artery denervation

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Pulmonary Hypertension, Remote magnetic navigation, Catheter ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

E. Meshalkin National Medical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Pulmonary vein isolation+sham pulmonary artery denervation (group 1)

Pulmonary vein isolation+pulmonary artery denervation (group 2)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia

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

Secondary Outcome Measures

Perioperative complications

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

Clinical adverse events

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

Number of hospitalizations

Hospitalizations due to atrial fibrillation of heart failure

Mean pulmonary artery pressure

Changes in mean pulmonary artery pressure between groups

Pulmonary vascular resistance

Changes in the pulmonary vascular resistance between groups

Pulmonary wedge pressure

Changes in the pulmonary wedge pressure between groups

Systolic pulmonary artery pressure

Changes in the systolic pulmonary artery pressure between groups

6-minutes walking distance

Changes in the 6-minutes walking distance between groups

Atrial fibrillation burden

Changes in the atrial fibrillation burden between groups

Brain natriuretic peptide

Changes in the brain natriuretic peptide between groups

Full Information

NCT ID

NCT05856461

First Posted

May 3, 2023

Last Updated

May 24, 2023

Sponsor

Meshalkin Research Institute of Pathology of Circulation

1. Study Identification

Unique Protocol Identification Number

NCT05856461

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 22, 2023 (Actual)

Primary Completion Date

December 29, 2024 (Anticipated)

Study Completion Date

February 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Pulmonary Hypertension

Keywords

Atrial fibrillation, Pulmonary Hypertension, Remote magnetic navigation, Catheter ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

2 parellel groups

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pulmonary vein isolation+sham pulmonary artery denervation (group 1)

Arm Type

Sham Comparator

Arm Description

Arm Title

Pulmonary vein isolation+pulmonary artery denervation (group 2)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Pulmonary vein isolation

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Sham pulmonary artery denervation

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Pulmonary artery denervation

Intervention Description

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)

Primary Outcome Measure Information:

Title

Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Perioperative complications

Description

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

Time Frame

30 days

Title

Clinical adverse events

Description

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

Time Frame

12 months

Title

Number of hospitalizations

Description

Hospitalizations due to atrial fibrillation of heart failure

Time Frame

12 months

Title

Mean pulmonary artery pressure

Description

Changes in mean pulmonary artery pressure between groups

Time Frame

12 months

Title

Pulmonary vascular resistance

Description

Changes in the pulmonary vascular resistance between groups

Time Frame

12 months

Title

Pulmonary wedge pressure

Description

Changes in the pulmonary wedge pressure between groups

Time Frame

12 months

Title

Systolic pulmonary artery pressure

Description

Changes in the systolic pulmonary artery pressure between groups

Time Frame

12 months

Title

6-minutes walking distance

Description

Changes in the 6-minutes walking distance between groups

Time Frame

12 months

Title

Atrial fibrillation burden

Description

Changes in the atrial fibrillation burden between groups

Time Frame

12 months

Title

Brain natriuretic peptide

Description

Changes in the brain natriuretic peptide between groups

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexander Romanov, MD

Phone

+73833327655

abromanov@mail.ru

First Name & Middle Initial & Last Name or Official Title & Degree

Vitaly Shabanov, MD

Phone

+73833327655

v.v.shabanov@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander B Romanov, MD

Organizational Affiliation

E. Meshalkin National Medical Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

E. Meshalkin National Medical Research Center

City

Novosibirsk

ZIP/Postal Code

630055

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexander B Romanov, MD

Phone

+73833327655

abromanov@mail.ru

First Name & Middle Initial & Last Name & Degree

Vitaly Shabanov, MD

Phone

+73833327655

v.v.shabanov@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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