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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVI group | Active Comparator | Conventional PVI by circumferential antral ablation according to standard procedures. |
|
| PVI+GP guided by SUMO technology group | Experimental | Conventional PVI by circumferential antral ablation according to standard procedures and atrial ganglionated plexi ablation guided by the SUMO technology. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary vein isolation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients without AF/AFl/AT | 12 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Romanov, MD, PhD | Contact | abromanov@mail.ru | ||
| Marina Nikitenko | Contact | m_nikitenko@meshalkin.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation | Recruiting | Novosibirsk | 630055 | Russia |
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|
| GP ablation guided by SUMO technology | Device | 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. |
|
| ILR implantation | Device | Implantation the ECG loop recorder according to standard procedure |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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