Intra-Cardiac Echocardiography Guided Cardioversion(ICE-CHIP) Study
Completed · Phase 1/Phase 2
Conditions studied: Atrial Fibrillation
In brief
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.
Key facts
- Study ID
- NCT00281073
- Run by
- EP MedSystems
- People needed
- 95
- Starts
- 2005-03-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2011-05-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Inclusion Criteria for the Phase I Component
- 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.
- Inclusion Criteria for the Phase II Component
- 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…
- Exclusion Criteria for the Phase I Component
- 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
- 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.
Where it is running
- Mayo Clinic — Jacksonville, Florida, United States
- University of Chicago - Center for Advanced Medicine — Chicago, Illinois, United States
- Carle Clinic — Urbana, Illinois, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Aurora Sinai Medical Center / St. Lukes Medical Center — Milwaukee, Wisconsin, United States
- Erasmus University Medical Center — Rotterdam, Rotterdam, Netherlands
Full record on ClinicalTrials.gov
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