NCT02492256

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

Atrial Ganglionated Plexi Ablation Guided by the SUMO Technology With and Without Conventional Pulmonary Vein Isolation in Persistent Atrial Fibrillation Patients: Prospective Randomized Study

• Status: Unknown
• Phase: 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: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Pulmonary 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.
DEVICE	GP 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.
DEVICE	ILR implantation	Implantation the ECG loop recorder according to standard procedure

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-05-01
• Completion: 2016-08-01
• First posted: 2015-07-08
• Last updated: 2015-07-08

Locations

1 site across 1 country: Russia