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

This study has been completed.
Sponsor:
Information provided by:
EP MedSystems
ClinicalTrials.gov Identifier:
NCT00281073
First received: January 23, 2006
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

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 acceptably low incidence rate of stroke, transient ischemic attack (TIA), peripheral embolism, and major hemorrhagic events following electrical cardioversion. This will be evaluated during the Phase II component of the study, after the Phase I objective is achieved.


Condition Intervention Phase
Atrial Fibrillation
Device: Intra-Cardiac Echocardiography guided Cardioversion
Device: Intracardiac Echo
Device: ICE
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Sequential Phase I - Phase II Pilot Study to Compare Cardiac Imaging Capabilities of ICE With TEE Followed by a Randomized Comparison of ICE Guided Cardioversion With Conventional Cardioversion Strategy in Patients With Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by EP MedSystems:

Primary Outcome Measures:
  • Prevalence of thrombi or spontaneous contrast detected by ICE or TEE [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    Prevalence of thrombi or spontaneous contrast detected by ICE


Enrollment: 95
Study Start Date: March 2005
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TEE and ICE
Serial use of TEE and ICE for comparative analysis
Device: Intra-Cardiac Echocardiography guided Cardioversion
Intracardiac Echo and TEE
Device: Intracardiac Echo
Intracardiac Echo Viewmate
Device: ICE
ICE or TEE
Active Comparator: ICE or TEE Device: ICE
ICE or TEE

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion Criteria for the Phase I Component

  1. Patients with spontaneous AF
  2. Patients with or without structural Heart Disease.
  3. Men or Women aged 18 years or older.
  4. Patients undergoing an invasive catheterization procedure including right heart catheterization.
  5. Patients who give an informed consent for participation in the study.
  6. Patients who have undergone a trans-thoracic echocardiogram within the last 14 days showing absence of intracardiac thrombi.
  7. Patients who have undergone a trans-esophageal echocardiogram within the last 48 hours.

Inclusion Criteria for the Phase II Component

  1. Patients with spontaneous AF
  2. Patients with or without structural Heart Disease.
  3. Men or Women aged 18 years or older.
  4. Patients undergoing an invasive catheterization procedure including right heart catheterization.
  5. Patients who give an informed consent for participation in the study.
  6. Patients who have undergone a trans-thoracic echocardiogram within the last 14 days showing absence of intracardiac thrombi.

Exclusion Criteria:

Exclusion Criteria for the Phase I Component

  1. Patients in whom placement of an ICE catheter for adequate atrial visualization is technically not feasible.
  2. Women of child bearing potential, in whom pregnancy cannot be excluded.
  3. Patients with any medical condition or social circumstance, which in the opinion of the investigator, would make the patient's successful completion of the study doubtful

Exclusion Criteria for the Phase II Component 1. Patients anticoagulated for > 7 days. 2. Patients who have had a cardioembolic event within the last 1-month. 3. Patients requiring urgent cardioversion due to hemodynamic instability. 4. Patients in whom placement of an ICE catheter for adequate atrial visualization is technically not feasible. 5. Patients with contraindications for Warfarin. 6. Women of child bearing potential, in whom pregnancy cannot be excluded. 7. Patients who need anticoagulation withdrawn due to an elective procedure 8. Patients with any medical condition or social circumstance, which in the opinion of the investigator would make the patient's successful completion of the study doubtful.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281073

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Illinois
University of Chicago - Center for Advanced Medicine
Chicago, Illinois, United States, 60637
Carle Clinic
Urbana, Illinois, United States, 61801
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Wisconsin
Aurora Sinai Medical Center / St. Lukes Medical Center
Milwaukee, Wisconsin, United States, 53215
Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands, 2040-3000CA
Sponsors and Collaborators
EP MedSystems
Investigators
Study Chair: Sanjeev Saksena, MD, FACC Professor, UMDNJ-RWJ Medical School
  More Information

Publications:
Fuster V, Ryden LE, Asinger RW, Cannom DS, Crijns HJ, Frye RL, Halperin JL, Kay GN, Klein WW, Levy S, McNamara RL, Prystowsky EN, Wann LS, Wyse DG; American College of Cardiology; American Heart Association; European Society of Cardiology; North American Society of Pacing and Electrophysiology. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to develop guidelines for the management of patients with atrial fibrillation) developed in collaboration with the North American Society of Pacing and Electrophysiology. Eur Heart J. 2001 Oct;22(20):1852-923. No abstract available.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanjeev Saksena MD, Electrophysiology Research Foundation, Warren, NJ
ClinicalTrials.gov Identifier: NCT00281073     History of Changes
Other Study ID Numbers: 2004-01
Study First Received: January 23, 2006
Last Updated: May 9, 2011
Health Authority: United States: Institutional Review Board
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by EP MedSystems:
Intra-Cardiac Echocardiography
Cardioversion

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 19, 2014