Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AF
Status unconfirmed · Not applicable
Conditions studied: Persistent Atrial Fibrillation
In brief
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 the likelihood of atrial fibrillation (AF) recurrence in patients with persistent atrial fibrillation at 12 months, after a single ablation procedure, in comparison to PVI alone. The investigator hypothesizes that the combination of PVI + PWI will result in a significant reduction in recurrence of atrial fibrillation at 12 months after ablation.
Key facts
- Study ID
- NCT04505163
- Run by
- Dignity Health Medical Foundation
- People needed
- 153
- Starts
- 2021-04-30
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2023-09-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mercy General Hospital and Dignity Health Medical Foundation — Sacramento, California, United States
- UCHealth Medical Center — Fort Collins, Colorado, United States
- MedStar Georgetown University Hospital and Medical Center — Washington D.C., District of Columbia, United States
- Sarasota Memorial Health Care System — Sarasota, Florida, United States
- Tampa Cardiac Specialists — Tampa, Florida, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Nebraska Methodist Hospital-Methodist Physicians Clinic — Omaha, Nebraska, United States
- Bethesda North Hospital — Cincinnati, Ohio, United States
- St. Luke's University Health Network — Bethlehem, Pennsylvania, United States
- Texas Cardiac Arrhythmia Institute & St. David's Medical Center — Austin, Texas, United States
Full record on ClinicalTrials.gov
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