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

NCT ID: NCT03370536

Last Updated: 2020-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2018-07-18

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-organized driver domains

3. Effect of PV isolation on driver domains

The researchers hypothesize that this approach will lead to successful arrhythmia control .

Conditions

Atrial Fibrillation; Persistent Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with AF

Patients with AF and planned to undergo first catheter procedure

Group Type: EXPERIMENTAL

CardioInsight ECGI Mapping System

Intervention Type: DEVICE

The CardioInsight mapping system is a noninvasive, single beat cardiac arrhythmia mapping system that provides 3D electroanatomic maps of the heart.

AF ablation

Intervention Type: PROCEDURE

Empiric ablation (CFAE or linear ablation) is not permitted

Ibutilide

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DEVICE

AF ablation

Empiric ablation (CFAE or linear ablation) is not permitted

Intervention Type: PROCEDURE

Ibutilide

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

Intervention Type: DRUG

Other Intervention Names

ECGi mapping; Biosense Thermocool SF; Biosense Smart Touch SF (STSF)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Vivek Reddy

OTHER

Sponsor Role: lead

Responsible Party

Vivek Reddy

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jacob Koruth, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Vivek Reddy, MD

Role: STUDY_CHAIR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GCO 40-5004

Identifier Type: -

Identifier Source: org_study_id