NCT02914860

Comparison of the Ganglionated Plexi Activity in Patients With Different Forms of Atrial Fibrillation Guided by SUMO Technology

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare DUA (discrete uptake accumulations) of mIBG activity in patients with different forms of atrial fibrillation and within a sub-group of healthy subjects.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Cardiac CT	* Cardiac CT - contract enhanced cardiac CT according to standard protocol * D-SPECT SUMO study - standard SUMO protocol (suggested reduction in mIBG dose and increase in scan time to minimize overall radiation burden) * Merge CT and D-SPECT image data to generate SUMO map.
PROCEDURE	Ablation Procedure	1. CARTO-reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO. 2. 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). 3. RF ablation only at points where there is an HFS positive response to SUMO DUA (in sinus rhythm if AF converts) 4. Target a region of 1.0 - 1.5 cm diameter around the SUMO mIBG DUA 5. Control HFS 6. At operator discretion, conventional PVI by circumferential antral ablation according to standard procedures. 7. Exit and entrance block confirmation 8. Attempt to induce sustained atrial tachycardia; optional mapping and ablation of post-ablation atrial tachycardia.
DEVICE	D-SPECT

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-05-01
• Completion: 2017-06-01
• First posted: 2016-09-26
• Last updated: 2016-09-26

Locations

1 site across 1 country: Russia