NCT03370536

ECGi Ibutilide: Effect of Ibutilide on AF Source Location and Organization

Panoramic ECGi to Guide Ablation of Non-Paroxysmal AF: Effect of Ibutilide on AF Source Location and Organization

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Vivek Reddy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, non-randomized, un-blinded, observational trial.

Detailed description

This prospective, multicenter observational study will examine the ability of ECGi mapping to 1. Effect of Ibutilide on the number and size of the driver domains 2. Effect of ablation of Ibutilide-organized driver domains 3. Effect of PV isolation on driver domains The researchers hypothesize that this approach will lead to successful arrhythmia control .

Conditions

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	CardioInsight ECGI Mapping System	The CardioInsight mapping system is a noninvasive, single beat cardiac arrhythmia mapping system that provides 3D electroanatomic maps of the heart.
PROCEDURE	AF ablation	Empiric ablation (CFAE or linear ablation) is not permitted
DRUG	Ibutilide	Progressive doses of Ibutilide administered (0.25mg, then 0.25mg, then 0.5mg)

Timeline

• Start date: 2017-11-01
• Primary completion: 2018-07-18
• Completion: 2018-07-18
• First posted: 2017-12-12
• Last updated: 2020-02-10
• Results posted: 2020-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study