Atrial Fibrillation
Conditions
Brief summary
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.
Interventions
DEVICEPulmonary vein isolation
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.
DEVICEGP ablation guided by SUMO technology
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.
DEVICEILR implantation
Implantation the ECG loop recorder according to standard procedure
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients without AF/AFl/AT | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to first recurrence of AF or atrial tachycardia (AF burden > 0,5%). | 12 month |
| Amount of mIBG uptake on 6 and 12 month DSPECT imaging in comparison to baseline D-SPECT. | 12 month |
Countries
Russia
Contacts
Primary ContactAlexander Romanov, MD, PhD
Backup ContactMarina Nikitenko
Outcome results
None listed