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
About this trial
This is an interventional treatment trial for Atrial Fibrillation
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
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
NCT ID
NCT02914860
First Posted
September 8, 2016
Last Updated
September 23, 2016
Sponsor
Meshalkin Research Institute of Pathology of Circulation
Collaborators
Spectrum Dynamics
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
We'll reach out to this number within 24 hrs