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Intra-Cardiac Echocardiography Guided Cardioversion to Help Interventional Procedures (ICE-CHIP) Study

This study is currently recruiting participants.
Verified by EP MedSystems, January 2006

Sponsored by: EP MedSystems
Information provided by: EP MedSystems
ClinicalTrials.gov Identifier: NCT00281073
  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
Phase I
Phase II

Genetics Home Reference related topics:   Brugada syndrome    familial atrial fibrillation    short QT syndrome   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by EP MedSystems:

Primary Outcome Measures:
  • Composite incidence of -
  • Stroke
  • Transient Ischemic Attack
  • Peripheral Embolism
  • Major hemorrhagic bleeding

Secondary Outcome Measures:
  • Prevalence of thrombi or spontaneous contrast detected by ICE,
  • Time to cardioversion following randomization
  • Minor bleeding events
  • Death and major procedure related complications (other than the primary endpoints)
  • Number of hospitalizations.
  • Quality of life

Estimated Enrollment:   300
Study Start Date:   March 2005
Estimated Study Completion Date:   March 2007

Show detailed description  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

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

Contacts
Contact: Ravi S. Mitruka, MBBS, MPH     (856)366-7156     rmitruka@epmedsystems.com    

Locations
United States, Florida
Mayo Clinic     Recruiting
      Jacksonville, Florida, United States, 32224
      Contact: Nathaniel Benson, CRC     904-953-7991     benson.nathaniel@mayo.edu    
      Contact: Kristin Steinbrecker     (904) 953-7536        
      Principal Investigator: Fred M Kusumoto, M.D.            
United States, Illinois
University of Chicago - Center for Advanced Medicine     Recruiting
      Chicago, Illinois, United States, 60637
      Contact: Al McAuley     773-702-5877     amcauley@medicine.bsd.uchicago.edu    
      Principal Investigator: Bradley P. Knight, M.D.            
Carle Clinic     Recruiting
      Urbana, Illinois, United States, 61801
      Contact: Kelly Rice, R.N.     217-326-0058     Kelly.rice@carle.com    
      Principal Investigator: Abraham Kocheril, M.D.            
United States, Ohio
Cleveland Clinic Foundation     Recruiting
      Cleveland, Ohio, United States, 44195
      Contact: Michael Sullivan, R.N     216-445-6883 ext 29402     sullivm4@ccf.org    
      Principal Investigator: Andre Natale, M.D.            
United States, Wisconsin
Aurora Sinai Medical Center / St. Lukes Medical Center     Recruiting
      Milwaukee, Wisconsin, United States, 53215
      Contact: Anthony Chambers, R.N.     414-385-2565     achamber@hrtcare.com    
      Principal Investigator: Jasbir S. Sra, MD, FACC            
Netherlands
Erasmus University Medical Center     Recruiting
      Rotterdam, Netherlands, 2040-3000CA
      Contact: Petter Janse     (10) 4632700     p.janse@erasmusmc.nl    
      Principal Investigator: Luc Jordaens, M.D.            

Sponsors and Collaborators
EP MedSystems

Investigators
Study Chair:     Sanjeev Saksena, MD, FACC     Professor, UMDNJ-RWJ Medical School    
  More Information

Publications:
Pearson AC, Labovitz AJ, Tatineni S, Gomez CR. Superiority of transesophageal echocardiography in detecting cardiac source of embolism in patients with cerebral ischemia of uncertain etiology. J Am Coll Cardiol. 1991 Jan;17(1):66-72.
 
Lin SL, Hsu TL, Liou JY, Chen CH, Chang MS, Chiang HT, Chen CY. Usefulness of transesophageal echocardiography for the detection of left atrial thrombi in patients with rheumatic heart disease. Echocardiography. 1992 Mar;9(2):161-8.
 
Castello R, Pearson AC, Labovitz AJ. Prevalence and clinical implications of atrial spontaneous contrast in patients undergoing transesophageal echocardiography. Am J Cardiol. 1990 May 1;65(16):1149-53.
 
Klein AL, Grimm RA, Murray RD, Apperson-Hansen C, Asinger RW, Black IW, Davidoff R, Erbel R, Halperin JL, Orsinelli DA, Porter TR, Stoddard MF; Assessment of Cardioversion Using Transesophageal Echocardiography Investigators. Use of transesophageal echocardiography to guide cardioversion in patients with atrial fibrillation. N Engl J Med. 2001 May 10;344(19):1411-20.
 
Packer DL, Stevens CL, Curley MG, Bruce CJ, Miller FA, Khandheria BK, Oh JK, Sinak LJ, Seward JB. Intracardiac phased-array imaging: methods and initial clinical experience with high resolution, under blood visualization: initial experience with intracardiac phased-array ultrasound. J Am Coll Cardiol. 2002 Feb 6;39(3):509-16.
 
Olgin JE, Kalman JM, Fitzpatrick AP, Lesh MD. Role of right atrial endocardial structures as barriers to conduction during human type I atrial flutter. Activation and entrainment mapping guided by intracardiac echocardiography. Circulation. 1995 Oct 1;92(7):1839-48.
 
Epstein LM, Smith T, TenHoff H. Nonfluoroscopic transseptal catheterization: safety and efficacy of intracardiac echocardiographic guidance. J Cardiovasc Electrophysiol. 1998 Jun;9(6):625-30.
 
Marrouche NF, Martin DO, Wazni O, Gillinov AM, Klein A, Bhargava M, Saad E, Bash D, Yamada H, Jaber W, Schweikert R, Tchou P, Abdul-Karim A, Saliba W, Natale A. Phased-array intracardiac echocardiography monitoring during pulmonary vein isolation in patients with atrial fibrillation: impact on outcome and complications. Circulation. 2003 Jun 3;107(21):2710-6. Epub 2003 May 19.
 
Mudra H, Klauss V, Blasini R, Kroetz M, Rieber J, Regar E, Theisen K. Ultrasound guidance of Palmaz-Schatz intracoronary stenting with a combined intravascular ultrasound balloon catheter. Circulation. 1994 Sep;90(3):1252-61.
 
Hijazi Z, Wang Z, Cao Q, Koenig P, Waight D, Lang R. Transcatheter closure of atrial septal defects and patent foramen ovale under intracardiac echocardiographic guidance: feasibility and comparison with transesophageal echocardiography. Catheter Cardiovasc Interv. 2001 Feb;52(2):194-9.
 
Ren JF, Marchlinski FE, Callans DJ. Left atrial thrombus associated with ablation for atrial fibrillation: identification with intracardiac echocardiography. J Am Coll Cardiol. 2004 May 19;43(10):1861-7.
 
Shanewise JS, Cheung AT, Aronson S, Stewart WJ, Weiss RL, Mark JB, Savage RM, Sears-Rogan P, Mathew JP, Quinones MA, Cahalan MK, Savino JS. ASE/SCA guidelines for performing a comprehensive intraoperative multiplane transesophageal echocardiography examination: recommendations of the American Society of Echocardiography Council for Intraoperative Echocardiography and the Society of Cardiovascular Anesthesiologists Task Force for Certification in Perioperative Transesophageal Echocardiography. J Am Soc Echocardiogr. 1999 Oct;12(10):884-900. No abstract available.
 
Petersen P, Boysen G, Godtfredsen J, Andersen ED, Andersen B. Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation. The Copenhagen AFASAK study. Lancet. 1989 Jan 28;1(8631):175-9.
 
[No authors listed] The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation. The Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators. N Engl J Med. 1990 Nov 29;323(22):1505-11.
 
[No authors listed] Stroke Prevention in Atrial Fibrillation Study. Final results. Circulation. 1991 Aug;84(2):527-39.
 
Connolly SJ, Laupacis A, Gent M, Roberts RS, Cairns JA, Joyner C. Canadian Atrial Fibrillation Anticoagulation (CAFA) Study. J Am Coll Cardiol. 1991 Aug;18(2):349-55.
 
[No authors listed] Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. EAFT (European Atrial Fibrillation Trial) Study Group. Lancet. 1993 Nov 20;342(8882):1255-62.
 
[No authors listed] Warfarin versus aspirin for prevention of thromboembolism in atrial fibrillation: Stroke Prevention in Atrial Fibrillation II Study. Lancet. 1994 Mar 19;343(8899):687-91.
 
[No authors listed] Adjusted-dose warfarin versus low-intensity, fixed-dose warfarin plus aspirin for high-risk patients with atrial fibrillation: Stroke Prevention in Atrial Fibrillation III randomised clinical trial. Lancet. 1996 Sep 7;348(9028):633-8.
 
Petersen P, Grind M, Adler J; SPORTIF II Investigators. Ximelagatran versus warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. SPORTIF II: a dose-guiding, tolerability, and safety study. J Am Coll Cardiol. 2003 May 7;41(9):1445-51.
 
Olsson SB; Executive Steering Committee on behalf of the SPORTIF III Investigators. Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): randomised controlled trial. Lancet. 2003 Nov 22;362(9397):1691-8.
 
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.
 

Study ID Numbers:   2004-01
First Received:   January 23, 2006
Last Updated:   January 23, 2006
ClinicalTrials.gov Identifier:   NCT00281073
Health Authority:   United States: Institutional Review Board;   Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by EP MedSystems:
Intra-Cardiac Echocardiography  
Cardioversion  

Study placed in the following topic categories:
Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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