Status:
TERMINATED
ECGi Ibutilide: Effect of Ibutilide on AF Source Location and Organization
Lead Sponsor:
Vivek Reddy
Collaborating Sponsors:
Medtronic
Conditions:
Atrial Fibrillation
Persistent Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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-or...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2018
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03370536
Start Date
November 1 2017
End Date
July 18 2018
Last Update
February 10 2020
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029