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

NCT02914860 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-09-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Spectrum Dynamics

    collaborator INDUSTRY

  • Meshalkin Research Institute of Pathology of Circulation

    lead NETWORK

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-05-31
Completion
2017-06-30

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02914860 on ClinicalTrials.gov