Status:
UNKNOWN
Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AF
Lead Sponsor:
Dignity Health Medical Foundation
Collaborating Sponsors:
Mercy General Hospital and Dignity Health Medical Foundation
Beth Israel Deaconess Medical Center
Conditions:
Persistent Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with isolation of the posterior left atrial wall (PWI) in the region of the pulmonary venous component will reduce th...
Detailed Description
Patients with persistent atrial fibrillation will be enrolled in this multi-center, randomized, prospective, single-blinded study. After catheter ablation (isolation) of the pulmonary veins (PVI) and ...
Eligibility Criteria
Inclusion
- Consistent with the current definitions, all patients with Persistent AF must exhibit an episode of continuous AF that is sustained \>7 days.
- Patients must have symptomatic Persistent AF refractory or intolerant to at least one class I or class III antiarrhythmic drug
- Males and females with an age \>18 years undergoing a first-time catheter ablation of AF; prior ablation of a right atrial cardiac arrhythmia (i.e., typical right atrial flutter) is permitted
- All patients must understand the requirements of the study and be willing to comply with the post-study follow-up requirements
- Patients must have documented episode of AF greater than 7 days in the year prior to the procedure
Exclusion
- History of long-standing persistent AF
- Any reversible cause of AF (post-operative, thyroid disorder, etc.)
- Patients with cerebral ischemic events (stroke or transient ischemic attack), myocardial infarction or unstable angina in the previous 2 months
- Patients with any corrected or uncorrected congenital heart disease
- Patients with a history of hypertrophic cardiomyopathy
- Patients with cardiomyopathy and a left ventricular ejection fraction \<40%
- Congestive heart failure, class IV
- Left atrial (LA) diameter \>55 mm (parasternal long axis view)
- Patients with left atrial thrombus
- Women who are known to be pregnant or have had a positive β-HCG (human chorionic gonadotropin) test 7 days prior to procedure
- Patients whose life expectancy is \<1 year
- History of left-sided left atrial ablation (catheter or surgically-based)
- Mental impairment precluding the patient from providing informed consent or completing appropriate follow-up
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT04505163
Start Date
April 30 2021
End Date
December 31 2024
Last Update
September 6 2023
Active Locations (11)
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1
Mercy General Hospital and Dignity Health Medical Foundation
Sacramento, California, United States, 95819
2
UCHealth Medical Center
Fort Collins, Colorado, United States, 80528
3
MedStar Georgetown University Hospital and Medical Center
Washington D.C., District of Columbia, United States, 20007
4
Sarasota Memorial Health Care System
Sarasota, Florida, United States, 34239