NCT03370536TerminatedNot Applicable
Panoramic ECGi to Guide Ablation of Non-Paroxysmal AF: Effect of Ibutilide on AF Source Location and Organization
Vivek Reddy1 site in 1 country1 target enrollmentStarted: November 1, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Number of Participants Who no Longer Has Recurrent At/AF
Study Overview
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
- Effect of Ibutilide on the number and size of the driver domains
- Effect of ablation of Ibutilide-organized driver domains
- Effect of PV isolation on driver domains
The researchers hypothesize that this approach will lead to successful arrhythmia control .
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patients with AF
Experimental
Patients with AF and planned to undergo first catheter procedure
Intervention: CardioInsight ECGI Mapping System (Device)
Patients with AF
Experimental
Patients with AF and planned to undergo first catheter procedure
Intervention: AF ablation (Procedure)
Patients with AF
Experimental
Patients with AF and planned to undergo first catheter procedure
Intervention: Ibutilide (Drug)
Outcomes
Primary Outcomes
Number of Participants Who no Longer Has Recurrent At/AF
Time Frame: at 12 months
Freedom from recurrent At/AF
Secondary Outcomes
- Number of Drivers(Baseline)
- Size of Drivers(Baseline)
- Percent Change of Driver Regions(Baseline and 1 year)
- AF Termination Rate(post ablation inducibility of AF after 5 minutes of burst pacing)
- Total Procedure Time(within 24 hours after the procedure is completed the time is calculated)
Investigators
Vivek Reddy
Professor
Icahn School of Medicine at Mount Sinai
Study Sites (1)
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