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

Stopped early · Not applicable

Conditions studied: Atrial Fibrillation, Persistent Atrial Fibrillation

In brief

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

Key facts

Study ID

NCT03370536

Run by

Vivek Reddy

People needed

1

Starts

2017-11-01

Expected to finish

2018-07-18

Last updated by the study team

2020-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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