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

Area of Science:

• Cardiology
• Medical Imaging
• Clinical Trials

Background:

• Atrial fibrillation (AF) management often involves cardioversion, traditionally requiring extensive anticoagulation.
• Transesophageal echocardiography (TEE) is used for pre-cardioversion assessment but is invasive.
• Intracardiac echocardiography (ICE) offers an alternative imaging modality during cardiac procedures.

Purpose of the Study:

• To compare the efficacy of ICE versus TEE in visualizing left atrial pathology, including thrombi and septal defects.
• To evaluate the safety and effectiveness of ICE-guided cardioversion compared to conventional strategies in AF patients.
• To identify low-risk AF patients suitable for immediate, in-procedure cardioversion.

Main Methods:

• A sequential Phase I and Phase II, prospective, open-label, randomized, multi-center study.
• Phase 1: 100 patients underwent both TEE and ICE imaging for blinded comparison of modalities.
• Phase 2: 300 patients randomized (3:2) to ICE-guided or conventional cardioversion, assessing composite cardiac and bleeding complications.

Main Results:

• Phase 1 demonstrated comparable efficacy of ICE to TEE in visualizing key left atrial structures.
• Phase 2 results are pending but aim to show non-inferiority of ICE-guided cardioversion.
• The study design allows for comparison of complication rates between immediate and delayed cardioversion strategies.

Conclusions:

• ICE is a viable alternative to TEE for cardiac imaging in AF patients.
• ICE-guided cardioversion may offer a safe and effective strategy, potentially reducing the need for prolonged anticoagulation.
• This approach could streamline AF management, especially in patients undergoing invasive cardiac procedures.