Actively Recruiting
Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm
Led by Saint Petersburg State University, Russia · Updated on 2024-12-20
125
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study is to evaluate benefits of electric cardioversion in the early and long-term postoperative period in patients after radiofrequency catheter isolation of pulmonary veins. Parameters of the left atrium will be evaluated by transthoracic echocardiography and electroanatomic mapping. Preservation of the sinus rhythm will be assessed by 24-hour electrocardiographic monitoring. The main question that is planned to be answered is: Does a reverse remodeling of the left atrium and/or a decrease in the progression of the fibrosis zone occur after performing electrical cardioversion (and before subsequent catheter ablation) in patients with persistent and long-standing persistent atrial fibrillation (AF)? Can performed electrical cardioversion serve as a predictor of AF freedom in this group of patients? Participants will undergo a follow-up examinations (echocardiography, ECG, 24-hour ECG monitoring) at the 3rd, 6th and 12th months after catheter ablation. Based on the results of these examinations, the recurrence rate of AF will be estimated. Two groups of patients will include both persistent and long-standing persistent AF. Experimental group will include patients who underwent electrical cardioversion before the intervention, and active comparator group will include those patients who did not undergo it. The experimental group will be subdivided into a persistent AF patients who were successfully cardioverted in sinus rhythm and persistent AF patients who failed to restore sinus rhythm during DC at the time of catheter ablation. Analysis and comparison of subgroups will be performed.
CONDITIONS
Official Title
Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent to participate in the study
- Persistent atrial fibrillation resistant to antiarrhythmic drugs for 6 months or more
- Left atrium size less than 55 mm
- Left atrium volume less than 130 ml
- Left atrium volume index less than 55 ml/m2
You will not qualify if you...
- Reversible causes of atrial fibrillation such as hyperthyroidism, pericarditis, or myocarditis
- Need for myocardial revascularization or heart valve disease correction
- Previous interventions including MAZE surgery, thoracoscopic ablation, or implanted left atrial occluder
- Severe other medical conditions requiring treatment
- Contraindications to anticoagulant therapy
- Presence of blood clot in left atrium or other reasons preventing catheter insertion
- Body mass index (BMI) of 40 or higher
AI-Screening
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Trial Site Locations
Total: 1 location
1
Saint Petersburg State University Clinic
Saint Petersburg, Sankt-Peterburg, Russia, 190020
Actively Recruiting
Research Team
A
Anton A Sheremet, MD
CONTACT
A
Aleksei A Filippov, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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