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

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Atrial Fibrillation

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

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT02914860

Volunteers+AF patients

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Volunteers

Experimental group

Description:

Healthy volunteers

Treatment:

Device: Cardiac CT

Device: D-SPECT

PAF

Active Comparator group

Description:

Patients with paroxysmal atrial fibrillation

Treatment:

Procedure: Ablation Procedure

Device: Cardiac CT

Device: D-SPECT

Pers AF

Active Comparator group

Description:

Patients with persistent atrial fibrillation

Treatment:

Procedure: Ablation Procedure

Device: Cardiac CT

Device: D-SPECT

L-s Pers AF

Active Comparator group

Description:

Patients with long-standing persistent atrial fibrillation

Treatment:

Procedure: Ablation Procedure

Device: Cardiac CT

Device: D-SPECT