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

NCT03370536 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-02-10

Study results available
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Summary

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

Conditions

Interventions

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)

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Vivek Reddy

    lead OTHER

Principal Investigators

  • Jacob Koruth, MD · Icahn School of Medicine at Mount Sinai

  • Vivek Reddy, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2018-07-18
Completion
2018-07-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03370536 on ClinicalTrials.gov