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

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Cardiac CT; Device: D-SPECT; Procedure: Ablation Procedure

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • Recruiting
    • State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female patients, age ≥ 18 and ≤ 80 years.
2. Male or female, age ≥ 50 years in the healthy volunteers group
3. No heart pathology (for volunteers)
4. PAF, Pers AF and L-s Pers AF (ECG documented).
5. LVEF ≥ 50%
6. Able to provide written informed consent
7. Able to comply with the requirements of the study

Exclusion Criteria:

1. Previous AF ablation therapy
2. Clinical evidence of active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality
3. Recent (3 months) myocardial infarction (MI), stroke or transient ischemic attack (except if the patient had a DES implanted stent post-MI it would be one year)
4. Contra-indication to Iodine-123 Meta-iodobenzylguanidine (123I-mIBG), iodine, isoproterenol
5. Use of medication for non-cardiac medical conditions that is known to interfere with 123I-mIBG uptake and cannot be safely withheld for at least 24 hours prior to the D-SPECT study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Volunteers; Healthy volunteers	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.; Device: D-SPECT
Active Comparator: PAF; Patients with paroxysmal atrial fibrillation	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.; Device: D-SPECT; Procedure: Ablation Procedure; 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 only at points where there is an HFS positive response to SUMO DUA (in sinus rhythm if AF converts); Target a region of 1.0 - 1.5 cm diameter around the SUMO mIBG DUA; Control HFS; At operator discretion, conventional PVI by circumferential antral ablation according to standard procedures.; Exit and entrance block confirmation; Attempt to induce sustained atrial tachycardia; optional mapping and ablation of post-ablation atrial tachycardia.
Active Comparator: Pers AF; Patients with persistent atrial fibrillation	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.; Device: D-SPECT; Procedure: Ablation Procedure; 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 only at points where there is an HFS positive response to SUMO DUA (in sinus rhythm if AF converts); Target a region of 1.0 - 1.5 cm diameter around the SUMO mIBG DUA; Control HFS; At operator discretion, conventional PVI by circumferential antral ablation according to standard procedures.; Exit and entrance block confirmation; Attempt to induce sustained atrial tachycardia; optional mapping and ablation of post-ablation atrial tachycardia.
Active Comparator: L-s Pers AF; Patients with long-standing persistent atrial fibrillation	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.; Device: D-SPECT; Procedure: Ablation Procedure; 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 only at points where there is an HFS positive response to SUMO DUA (in sinus rhythm if AF converts); Target a region of 1.0 - 1.5 cm diameter around the SUMO mIBG DUA; Control HFS; At operator discretion, conventional PVI by circumferential antral ablation according to standard procedures.; Exit and entrance block confirmation; Attempt to induce sustained atrial tachycardia; optional mapping and ablation of post-ablation atrial tachycardia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
location of discrete uptake accumulations	1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
adverse events	1 week

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Collaborators: Spectrum Dynamics

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 23, 2016
• First Posted (Estimate): September 26, 2016

Study Record Updates

• Last Update Posted (Estimate): September 26, 2016
• Last Update Submitted That Met QC Criteria: September 23, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Volunteers+AF patients