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

NCT02914860 | Unknown Phase 1

• 1 other identifier: Volunteers+AF patients
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• location of discrete uptake accumulations

  1 week

Secondary Outcomes (1)

• adverse events

  1 week

Study Arms (4)

Volunteers

EXPERIMENTAL

Healthy volunteers

Device: Cardiac CT; Device: D-SPECT

PAF

ACTIVE COMPARATOR

Patients with paroxysmal atrial fibrillation

Device: Cardiac CT; Procedure: Ablation Procedure; Device: D-SPECT

Pers AF

ACTIVE COMPARATOR

Patients with persistent atrial fibrillation

Device: Cardiac CT; Procedure: Ablation Procedure; Device: D-SPECT

L-s Pers AF

ACTIVE COMPARATOR

Patients with long-standing persistent atrial fibrillation

Device: Cardiac CT; Procedure: Ablation Procedure; Device: D-SPECT

Interventions

Cardiac CT DEVICE

* 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.

L-s Pers AF; PAF; Pers AF; Volunteers

Ablation Procedure 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.

L-s Pers AF; PAF; Pers AF

D-SPECT DEVICE

L-s Pers AF; PAF; Pers AF; Volunteers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous AF ablation therapy
• Clinical evidence of active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality
• 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)
• Contra-indication to Iodine-123 Meta-iodobenzylguanidine (123I-mIBG), iodine, isoproterenol
• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead
• Spectrum Dynamics: collaborator

Study Sites (1)

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Novosibirsk, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alexander Romanov

CONTACT

abromanov@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 26, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 26, 2016

Record last verified: 2016-09

Locations

RU (1)