Comparison of the Ganglionated Plexi Activity in Patients With Different Forms of Atrial Fibrillation Guided by SUMO Technology
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- location of discrete uptake accumulations
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
- •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
Arms & Interventions
Volunteers
Healthy volunteers
Intervention: Cardiac CT (Device)
Volunteers
Healthy volunteers
Intervention: D-SPECT (Device)
PAF
Patients with paroxysmal atrial fibrillation
Intervention: Cardiac CT (Device)
PAF
Patients with paroxysmal atrial fibrillation
Intervention: Ablation Procedure (Procedure)
PAF
Patients with paroxysmal atrial fibrillation
Intervention: D-SPECT (Device)
Pers AF
Patients with persistent atrial fibrillation
Intervention: D-SPECT (Device)
Pers AF
Patients with persistent atrial fibrillation
Intervention: Cardiac CT (Device)
Pers AF
Patients with persistent atrial fibrillation
Intervention: Ablation Procedure (Procedure)
L-s Pers AF
Patients with long-standing persistent atrial fibrillation
Intervention: Cardiac CT (Device)
L-s Pers AF
Patients with long-standing persistent atrial fibrillation
Intervention: Ablation Procedure (Procedure)
L-s Pers AF
Patients with long-standing persistent atrial fibrillation
Intervention: D-SPECT (Device)
Outcomes
Primary Outcomes
location of discrete uptake accumulations
Time Frame: 1 week
Secondary Outcomes
- adverse events(1 week)