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Sponsored by: |
EP MedSystems |
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Information provided by: | EP MedSystems |
ClinicalTrials.gov Identifier: | NCT00281073 |
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 |
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Atrial Fibrillation |
Device: Intra-Cardiac Echocardiography guided Cardioversion |
Phase I Phase II |
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 |
Estimated Enrollment: | 300 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | March 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion Criteria for the Phase I Component
Inclusion Criteria for the Phase II Component
Exclusion Criteria:
Exclusion Criteria for the Phase I Component
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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Contact: Ravi S. Mitruka, MBBS, MPH | (856)366-7156 | rmitruka@epmedsystems.com |
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. |
Study Chair: | Sanjeev Saksena, MD, FACC | Professor, UMDNJ-RWJ Medical School |
Study ID Numbers: | 2004-01 |
Study First Received: | January 23, 2006 |
Last Updated: | January 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00281073 History of Changes |
Health Authority: | United States: Institutional Review Board; Netherlands: Medical Ethics Review Committee (METC) |
Intra-Cardiac Echocardiography Cardioversion |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |