Atrial Ganglionated Plexi Ablation Guided by the SUMO Technology With and Without Conventional Pulmonary Vein Isolation in Patients With Persistent AF

Meshalkin Research Institute of Pathology of Circulation60 enrolled

Overview

Although circumferential pulmonary vein isolation (PVI) has been considered as the cornerstone for atrial fibrillation ablation, there has been a substantial recurrence rate. The investigators designed a prospectively randomized study to evaluate whether additional atrial ganglionated plexi ablation guided by the SUMO technology improves the clinical outcome in patients with persistent AF.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Atrial Fibrillation

Interventions

Pulmonary vein isolationDEVICE

CARTO- reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO. Conventional PVI by circumferential antral ablation according to standard procedures. Exit and Entrance block conformation. Attempt to induce sustained atrial tachycardia. Optional mapping and ablation of post-ablation atrial tachycardia.

GP ablation guided by SUMO technologyDEVICE

CARTO- reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO. High frequency stimulation (HFS; 20-Hz frequency, 5-ms pulse duration, and 15-mA output) to access positive vagal response (the heart rate decreasing by 50% at baseline). RF Ablation of SUMO hotspots (in sinus rhythm if AF converts) • Target a region of 1.0-1.5 cm diameter around the SUMO 'hotspot'. Control HFS. Attempt to induce sustained atrial tachycardia. Optional mapping and ablation of post-ablation atrial tachycardia.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female patients, age ≥ 18 and ≤ 80 years. 2. Persistent AF (ECG documentation). 3. Indication for AF ablation. 4. LVEF ≥ 50% 5. Able to provide written informed consent 6. Able to comply with the requirements of the study Exclusion Criteria: 1. Reversible cause of atrial fibrillation 2. Previous AF ablation therapy 3. Clinical evidence of active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality 4. Recent (3 months) myocardial infarction (MI), stroke or transient ischemic attack (except if the patient had a DES implanted stent post-MI it would be one year) 5. Contra-indication to Iodine-123 Meta-iodobenzylguanidine (123I-mIBG), iodine, isoproterenol 6. Use of medication for non-cardiac medical conditions that is known to interfere with 123I-mIBG uptake and cannot be safely withheld for at least 24 hours prior to the D-SPECT study procedures 7. Inability to undergo D-SPECT and CT imaging

Locations (1)

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Novosibirsk, Russia

RECRUITING

Outcomes

Primary Outcomes

Number of patients without AF/AFl/AT

Time frame: 12 months

Secondary Outcomes

Time to first recurrence of AF or atrial tachycardia (AF burden > 0,5%).

Time frame: 12 month

Amount of mIBG uptake on 6 and 12 month DSPECT imaging in comparison to baseline D-SPECT.

Time frame: 12 month

Central Contacts

Alexander Romanov, MD, PhD

CONTACT

abromanov@mail.ru

Marina Nikitenko

CONTACT

m_nikitenko@meshalkin.ru

Data from ClinicalTrials.gov

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