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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 12
- 主要终点
- Prevalence of thrombi or spontaneous contrast detected by ICE or TEE
研究概览
简要总结
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.
详细描述
The presence of intra-atrial thrombi or their precursors with their propensity for systemic embolism or the presence of interatrial septal defects are major concerns for patients with atrial fibrillation (AF) undergoing cardioversion. Transesophageal echocardiography (TEE) has been demonstrated to be a sensitive tool to detect septal defects, left atrial thrombi and spontaneous echo contrast (1, 2,3). The ACUTE trial documented that TEE based exclusion of intra cardiac thrombi, smoke or spontaneous echo contrast can facilitate safe immediate cardioversion in patients with AF. (4) This trial demonstrated comparable risk of embolic events with a TEE- based strategy to identify low risk patients for immediate cardioversion when compared to a conventional strategy of 3 weeks of anticoagulation before cardioversion.
The recognition of systemic thromboembolism as a significant potential complication of cardioversion during interventional cardiology procedures in patients with AF has stimulated interest in the clinical evaluation of catheter based intra cardiac echocardiography (ICE). Initial experience with intra cardiac phased -array imaging has demonstrated the efficacy and feasibility of this technology for intracardiac application and its capability in high resolution imaging of endocardial structures. (5) In the recent times, the utility of this imaging modality in various interventional procedures has been investigated and its effectiveness in visualizing left atrial thrombi during ablative procedures has been demonstrated in observational studies. (6 -11) However, a prospective multicenter comparative study of these two imaging techniques is unavailable. Should ICE provide comparable imaging capabilities to TEE, the value of ICE guided cardioversion during invasive procedures can also then be systematically studied during a prospective multicenter clinical study.
The ICE CHIP study 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).
In Phase I, 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 II, patients will be randomized to one of the two treatment groups. Investigators will be blinded to the method of management for each patient prior to their enrollment into the study. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Patients anticoagulated for > 7 days.
- •Patients who have had a cardioembolic event within the last 1-month.
- •Patients requiring urgent cardioversion due to hemodynamic instability.
- •Patients in whom placement of an ICE catheter for adequate atrial visualization is technically not feasible.
- •Patients with contraindications for Warfarin.
- •Women of child bearing potential, in whom pregnancy cannot be excluded.
- •Patients who need anticoagulation withdrawn due to an elective procedure
- •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.
结局指标
主要结局
Prevalence of thrombi or spontaneous contrast detected by ICE or TEE
时间窗: intraoperative
Prevalence of thrombi or spontaneous contrast detected by ICE
次要结局
未报告次要终点