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

• Status: Terminated
• Trial end date: 2018-07-18
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vivek Reddy
• Collaborator: Medtronic
• Treatments: Ibutilide

Criteria

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