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

NCT05856461 | Unknown

• 1 other identifier: MEN_02052023
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation; Pulmonary Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia

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

  12 months

Secondary Outcomes (10)

• Perioperative complications

  30 days

• Clinical adverse events

  12 months

• Number of hospitalizations

  12 months

• Mean pulmonary artery pressure

  12 months

• Pulmonary vascular resistance

  12 months

Study Arms (2)

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

SHAM COMPARATOR

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; Procedure: Sham pulmonary artery denervation

Pulmonary vein isolation+pulmonary artery denervation (group 2)

ACTIVE COMPARATOR

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; Procedure: Pulmonary artery denervation

Interventions

Pulmonary vein isolation PROCEDURE

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

Pulmonary vein isolation+pulmonary artery denervation (group 2); Pulmonary vein isolation+sham pulmonary artery denervation (group 1)

Sham pulmonary artery denervation PROCEDURE

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 vein isolation+sham pulmonary artery denervation (group 1)

Pulmonary artery denervation PROCEDURE

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)

Pulmonary vein isolation+pulmonary artery denervation (group 2)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

E. Meshalkin National Medical Research Center

Novosibirsk, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Study Officials

• Alexander B Romanov, MD

  E. Meshalkin National Medical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Romanov, MD

CONTACT

+73833327655; abromanov@mail.ru

Vitaly Shabanov, MD

CONTACT

+73833327655; v.v.shabanov@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 2 parellel groups

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 12, 2023
• Study Start: May 22, 2023
• Primary Completion: December 29, 2024
• Study Completion: February 22, 2025
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

RU (1)