Status:
COMPLETED
Effect of Balloon Cryoablation on Left Atrial Function
Lead Sponsor:
Vivek Reddy
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Atrial fibrillation is a common and disabling irregular heart rhythm, that affects 1 to 1.5 million Americans. Recent clinical experience with the Medtronic Arctic Front™ Cardiac CryoAblation Catheter...
Detailed Description
This study is a prospective, non-randomized, single-center, controlled study of patients with AF referred for ablation after failing one or more Class I-IV antiarrhythmic drugs used in the treatment o...
Eligibility Criteria
Inclusion
- Documented paroxysmal atrial fibrillation
- ≥ 18 and ≤ 85 years of age
- Failure of one or more AF Drugs (AFDs).
- Referral for a pulmonary vein isolation catheter ablation procedure to treat atrial fibrillation
- Ability to understand the requirements of the study
- Willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements
Exclusion
- Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
- More than 4 cardioversions in the prior year.
- Patients with recent myocardial infarction (less than 2 months) or unstable angina.
- Patients with congestive heart failure (NYHA class III or IV).
- Patients who have experienced any cerebral ischemic event, including any TIA in the preceding 1 month.
- Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure.
- Patients with any other significant uncontrolled or unstable medical condition (including uncontrolled clinically significant coagulation disorders).
- Patients whose life expectancy is less than one year.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00821015
Start Date
June 1 2010
End Date
June 1 2012
Last Update
July 5 2019
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.