Status:
COMPLETED
Intra-Cardiac Echocardiography Guided Cardioversion(ICE-CHIP) Study
Lead Sponsor:
EP MedSystems
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 (Pha...
Detailed Description
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 fibrillat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- \-
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00281073
Start Date
March 1 2005
End Date
July 1 2008
Last Update
May 11 2011
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Jacksonville, Florida, United States, 32224
2
University of Chicago - Center for Advanced Medicine
Chicago, Illinois, United States, 60637
3
Carle Clinic
Urbana, Illinois, United States, 61801
4
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195