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

Vivek Reddy

Status: Terminated

Conditions: Atrial Fibrillation; Persistent Atrial Fibrillation

Treatments: Device: CardioInsight ECGI Mapping System; Procedure: AF ablation; Drug: Ibutilide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03370536

GCO 40-5004

Details and patient eligibility

About

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

Full 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 .

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 18 years of age.

• ° Symptomatic persistent AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication Persistent AF - defined as Persistent: AF that is sustained > 7 days. Episodes of AF which are terminated by electrical or pharmacologic cardioversion after ≥ 48 hours of AF, but prior to 7 days, should also be classified as persistent AF episodes.

  • Planned to undergo first catheter ablation procedure ( prior atrial flutter typical is allowed)

• Ability to understand the requirements of the study and sign the informed consent form.

• Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements

• Projected lifespan greater than 1 year

Exclusion criteria

• They have baseline prolonged QT or renal failure precluding safe used of ibutilide
• Rheumatic heart disease,
• Current intra-cardiac thrombus,
• History of MI or CABG within 6 weeks;
• Class IV HF,
• Unable to sign consent
• Projected lifespan of < 1 year
• Women known to be pregnant or to have positive beta-HCG.
• Participation in another study that would interfere with this study.
• Unstable Angina
• Recent cerebral ischemic events
• Contraindication to anticoagulation
• Prior history of polymorphic ventricular tachycardia or torsades de pointes

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Patients with AF

Experimental group

Description:

Patients with AF and planned to undergo first catheter procedure

Treatment:

Procedure: AF ablation

Device: CardioInsight ECGI Mapping System

Drug: Ibutilide