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

Atrial Fibrillation Clinical Trial

Official title:

Panoramic ECGi to Guide Ablation of Non-Paroxysmal AF: Effect of Ibutilide on AF Source Location and Organization

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03370536
• Other study ID #: GCO 40-5004
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: July 18, 2018

Study information

• Verified date: January 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 18, 2018
• Est. primary completion date: July 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• CardioInsight ECGI Mapping System
The CardioInsight mapping system is a noninvasive, single beat cardiac arrhythmia mapping system that provides 3D electroanatomic maps of the heart.

Procedure:
• AF ablation
Empiric ablation (CFAE or linear ablation) is not permitted

Drug:
• Ibutilide
Progressive doses of Ibutilide administered (0.25mg, then 0.25mg, then 0.5mg)

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Vivek Reddy	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who no Longer Has Recurrent At/AF	Freedom from recurrent At/AF	at 12 months
Secondary	Number of Drivers	Number of drivers identified	Baseline
Secondary	Size of Drivers	Size of drivers ablated	Baseline
Secondary	Percent Change of Driver Regions	Percent change of driver regions after ibutilide	Baseline and 1 year
Secondary	AF Termination Rate	AF termination rate is defined as AF termination to AT/SR (Atrial Tachycardia/Sinus Rhythm)	post ablation inducibility of AF after 5 minutes of burst pacing
Secondary	Total Procedure Time	Total duration of RF ablation/fluoroscopy time/exposure procedure time	within 24 hours after the procedure is completed the time is calculated