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

NCT00281073 | Completed Phase 1 DMC

• 1 other identifier: 2004-01
• Study Type: interventional
• Target: 95
• Locations: 2 countries
• Sites: 6

Brief 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 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.

Conditions

Atrial Fibrillation

Keywords

Intra-Cardiac Echocardiography; Cardioversion

Outcome Measures

Primary Outcomes (1)

• Prevalence of thrombi or spontaneous contrast detected by ICE or TEE

  Prevalence of thrombi or spontaneous contrast detected by ICE

  intraoperative

Study Arms (2)

TEE and ICE

ACTIVE COMPARATOR

Serial use of TEE and ICE for comparative analysis

Device: Intra-Cardiac Echocardiography guided Cardioversion; Device: Intracardiac Echo; Device: ICE

ICE or TEE

ACTIVE COMPARATOR

Device: ICE

Interventions

Intra-Cardiac Echocardiography guided Cardioversion DEVICE

Intracardiac Echo and TEE

TEE and ICE

Intracardiac Echo DEVICE

Intracardiac Echo Viewmate

TEE and ICE

ICE DEVICE

ICE or TEE

ICE or TEE; TEE and ICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients in whom placement of an ICE catheter for adequate atrial visualization is technically not feasible.
• Women of child bearing potential, in whom pregnancy cannot be excluded.
• 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

Sponsors & Collaborators

• EP MedSystems: lead

Study Sites (6)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

University of Chicago - Center for Advanced Medicine

Chicago, Illinois, 60637, United States

Location

Carle Clinic

Urbana, Illinois, 61801, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Aurora Sinai Medical Center / St. Lukes Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Erasmus University Medical Center

Rotterdam, Rotterdam, 2040-3000CA, Netherlands

Location

Related Publications (23)

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• Saksena S, Sra J, Jordaens L, Kusumoto F, Knight B, Natale A, Kocheril A, Nanda NC, Nagarakanti R, Simon AM, Viggiano MA, Lokhandwala T, Chandler ML; ICE-CHIP Investigator Study Group. A prospective comparison of cardiac imaging using intracardiac echocardiography with transesophageal echocardiography in patients with atrial fibrillation: the intracardiac echocardiography guided cardioversion helps interventional procedures study. Circ Arrhythm Electrophysiol. 2010 Dec;3(6):571-7. doi: 10.1161/CIRCEP.110.936161. Epub 2010 Sep 18.

  PMID: 20852299 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sanjeev Saksena, MD, FACC

  Professor, UMDNJ-RWJ Medical School

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 23, 2006
• First Posted: January 24, 2006
• Study Start: March 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: July 1, 2008
• Last Updated: May 11, 2011

Record last verified: 2011-05

Locations

US (5); NL (1)