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

Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02914860
• Other study ID #: Volunteers+AF patients
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: September 8, 2016
• Last updated: September 23, 2016
• Start date: September 2016
• Est. completion date: June 2017

Study information

• Verified date: September 2016
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Alexander Romanov
• Email: abromanov[@]mail.ru
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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
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.

Device:
• D-SPECT

Locations

Country	Name	City	State
Russian Federation	State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation	Novosibirsk

Sponsors (2)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation	Spectrum Dynamics

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	location of discrete uptake accumulations		1 week	Yes
Secondary	adverse events		1 week	Yes