Intra-cardiac echocardiography guided cardioversion to help interventional procedures (ICE-CHIP) study: study design and methods.

The ICE CHIP study is a sequential Phase I and Phase II pilot study comparing the cardiac imaging capabilities of intracardiac echocardiography (ICE) with with transesophageal echocardiography (TEE) followed by a randomized comparison of ICE guided cardioversion with a conventional cardioversion strategy in patients with atrial fibrillation. It is a prospective open label randomized multi-center investigation performed in two phases designed to initially compare two distinct imaging modalities (Phase 1) and subsequently two different strategies (ICE guided Cardioversion and Conventional) in the management of AF in patients undergoing invasive cardiac procedures in whom electrical cardioversion is indicated (Phase 2). This study will examines two hypotheses in AF patients undergoing invasive cardiac procedures: (1) ICE has comparable efficacy to TEE in visualization of left atrial pathology including thrombi or interatrial septal defects. This will be evaluated during the Phase I component of the study. (2) 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. Phase 1 will enroll 100 patients at 12 centers, who will undergo a clinically indicated TEE procedure and cardiac catheterization procedure. Each patient will be imaged by TEE & ICE and a core echo laboratory will perform a blinded comparison of the two imaging modalities. In Phase 2, a total of 300 patients (3:2 randomization) will be enrolled in the study at up to 15 investigational sites in USA and Europe. The composite incidence rate of major cardiac and bleeding complications (stroke, TIA, peripheral embolism, major hemorrhagic event) will be compared between the two treatment groups over the duration of the study.