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NCT00281073 · ClinicalTrials.gov registry record · Phase 1

Intra-Cardiac Echocardiography Guided Cardioversion(ICE-CHIP) Study

A Phase 1 study of Atrial Fibrillation, sponsored by EP MedSystems.

Completed
Registry status
Phase 1
Development phase
95
Enrollment target
6
Study locations

NCT00281073 is a Phase 1 study of Atrial Fibrillation that has completed, run by EP MedSystems. The registered enrollment target is 95 participants, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (97% lower). The trial reports 6 study locations across 5 states.

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The verdict

NCT00281073, a Phase 1 study of Atrial Fibrillation, has completed, sponsored by EP MedSystems.

COMPLETED
Registry status
Phase 1
Development phase
95 participants
Enrollment target
6
Study locations

Study Summary

This is a sequential phase 1 and phase 2 study to evaluate the efficacy of intracardiac echocardiography to detect septal and left atrial pathology as compared to transesophageal echocardiography (Phase 1) and its value in a management strategy for immediate cardioversion during cardiac catheterization procedures in patients with atrial fibrillation as compared to a conventional strategy delaying cardioversion till full anticoagulation is established for a three weeks (Phase 2). Phase 1 will enroll 100 patients at 12 centers; these patients will be undergoing clinically indicated TEE \& cardiac catheterization procedures. After review of Phase 1 results by an independent DSMB \& the investigators that establish efficacy of ICE, Phase 2 will be initiated. Phase 2 will enroll 300 patients in 15 centers; these patients with atrial fibrillation will be undergoing clinically indicated cardiac catheterization procedures and have a clinical indication for cardioversion. Patients will be randomized to ICE guided cardioversion strategy or a conventional strategy employing three weeks of full anticoagulation before cardioversion. ICE imaging will be used to identify a low risk group for immediate cardioversion. A composite primary study endpoint that will include mortality and major morbidity including stroke and bleeding complications will be used. This study will examines two hypotheses in AF patients undergoing invasive cardiac procedures: Hypothesis 1: That ICE has comparable efficacy to TEE in visualization of left atrial pathology or septal defects that can predispose patients to stroke. This will be evaluated during the Phase I component of the study. Hypothesis 2: That ICE can identify low risk patients in whom immediate cardioversion during the procedure is safe and comparably effective to electrical cardioversion performed based on a conventional strategy of a minimum of 3 weeks of preceding anticoagulation therapy. Low risk patients are expected to have an accep

Conditions Studied

Atrial Fibrillation

Interventions

  • DEVICE Intra-Cardiac Echocardiography guided Cardioversion
  • DEVICE Intracardiac Echo
  • DEVICE ICE

Study Locations (6)

Illinois

  • University of Chicago - Center for Advanced Medicine - Chicago
  • Carle Clinic - Urbana

Florida

  • Mayo Clinic - Jacksonville

Ohio

  • Cleveland Clinic Foundation - Cleveland

Wisconsin

  • Aurora Sinai Medical Center / St. Lukes Medical Center - Milwaukee

Rotterdam

  • Erasmus University Medical Center - Rotterdam

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2005-03
Est. Completion 2008-07
Phase Phase 1

Sponsor

EP MedSystems

1 total trials

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What the Registry Record Tells You About NCT00281073

The ClinicalTrials.gov registry entry for NCT00281073 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (97% lower). The listed sponsor is EP MedSystems, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 3 interventions - of which Intra-Cardiac Echocardiography guided Cardioversion is the first listed.

NCT00281073 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Illinois, Florida, Ohio.

Frequently Asked Questions

What is clinical trial NCT00281073 about?

NCT00281073 is a clinical study titled "Intra-Cardiac Echocardiography Guided Cardioversion(ICE-CHIP) Study". This is a sequential phase 1 and phase 2 study to evaluate the efficacy of intracardiac echocardiography to detect septal and left atrial pathology as compared to transesophageal echocardiography (Phase 1) and its value in a management strategy for immediate cardioversion during cardiac catheterizat...

What is the current status of trial NCT00281073?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2005-03. Estimated completion is 2008-07.

What conditions does trial NCT00281073 study?

This clinical trial studies the following conditions: Atrial Fibrillation.

What interventions are being tested in trial NCT00281073?

The interventions under investigation include: Intra-Cardiac Echocardiography guided Cardioversion (DEVICE), Intracardiac Echo (DEVICE), ICE (DEVICE).

Who is sponsoring clinical trial NCT00281073?

This trial is sponsored by EP MedSystems, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00281073 being conducted?

This trial has 6 study locations across Florida, Illinois, Ohio, Wisconsin, Rotterdam. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.