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

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

May 31, 2017

Study Completion Date

June 30, 2017

Conditions
Atrial Fibrillation
Interventions
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

Trial Locations (1)

630055

RECRUITING

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation, Novosibirsk

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Spectrum Dynamics

INDUSTRY

lead

Meshalkin Research Institute of Pathology of Circulation

NETWORK

NCT02914860 - Comparison of the Ganglionated Plexi Activity in Patients With Different Forms of Atrial Fibrillation Guided by SUMO Technology | Biotech Hunter | Biotech Hunter