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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Cardiac CT
Ablation Procedure
D-SPECT
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • State Research Institute of CIrculation Pathology Novosibirsk, Russian FederationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Volunteers

PAF

Pers AF

L-s Pers AF

Arm Description

Healthy volunteers

Patients with paroxysmal atrial fibrillation

Patients with persistent atrial fibrillation

Patients with long-standing persistent atrial fibrillation

Outcomes

Primary Outcome Measures

location of discrete uptake accumulations

Secondary Outcome Measures

adverse events

Full Information

First Posted
September 8, 2016
Last Updated
September 23, 2016
Sponsor
Meshalkin Research Institute of Pathology of Circulation
Collaborators
Spectrum Dynamics
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1. Study Identification

Unique Protocol Identification Number
NCT02914860
Brief Title
Comparison of the Ganglionated Plexi Activity in Patients With Different Forms of Atrial Fibrillation Guided by SUMO Technology
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
Collaborators
Spectrum Dynamics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Volunteers
Arm Type
Experimental
Arm Description
Healthy volunteers
Arm Title
PAF
Arm Type
Active Comparator
Arm Description
Patients with paroxysmal atrial fibrillation
Arm Title
Pers AF
Arm Type
Active Comparator
Arm Description
Patients with persistent atrial fibrillation
Arm Title
L-s Pers AF
Arm Type
Active Comparator
Arm Description
Patients with long-standing persistent atrial fibrillation
Intervention Type
Device
Intervention Name(s)
Cardiac CT
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ablation Procedure
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
D-SPECT
Primary Outcome Measure Information:
Title
location of discrete uptake accumulations
Time Frame
1 week
Secondary Outcome Measure Information:
Title
adverse events
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Romanov
Email
abromanov@mail.ru
Facility Information:
Facility Name
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
Phone
+79139254858
Email
E.Pokushalov@gmail.com
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alexander Romanov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Denis Losik

12. IPD Sharing Statement

Learn more about this trial

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

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