Impact of Pre-Ablation Direct Current Cardioversion for Persistent Atrial Fibrillation to Predict Recurrence of Atrial Fibrillation after Catheter Ablation.
Hiroyuki Kamada, Kazuki Mori, Nobuhiko Ueda...
https://pubmed.ncbi.nlm.nih.gov/36184544Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06654401
Electrical Cardioversion as a Predictor in Postoperative Sinus Rhythm Preservation in Patients with Persistent Atrial Fibrillation Before Radiofrequency Pulmonary Vein Isolation
Led by Saint Petersburg State University, Russia · Updated on 2024-12-20
125
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the potential benefits of electric cardioversion in patients with persistent and long-standing persistent atrial fibrillation (AF) undergoing radiofrequency catheter isolation of pulmonary veins. The study aims to determine whether electric cardioversion before catheter ablation can lead to reverse remodeling of the left atrium and reduce fibrosis progression, possibly serving as a predictor of freedom from AF. The left atrium's condition will be assessed by transthoracic echocardiography and electroanatomic mapping, while sinus rhythm preservation will be monitored with 24-hour ECG. Participants will be divided into two main groups: those who receive electric cardioversion before pulmonary vein isolation (experimental group) and those who do not (active comparator). Within the experimental group, patients will be further categorized based on whether sinus rhythm was successfully restored by cardioversion at the time of catheter ablation. The primary intervention involves radiofrequency pulmonary vein isolation, performed with or without prior cardioversion depending on group assignment. During the trial, participants will undergo follow-up examinations at 3, 6, and 12 months after catheter ablation, including echocardiography and 24-hour ECG monitoring to assess atrial remodeling and AF recurrence. In addition, patients will complete quality of life questionnaires at these intervals. The main outcome measured is freedom from atrial fibrillation six months after ablation, with additional assessments at 12 months and evaluation of heart function improvements. Safety and effectiveness will be carefully monitored throughout the study period.
CONDITIONS
Brief Title
Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent to participate in the study
- Persistent atrial fibrillation lasting 6 months or more that does not respond to antiarrhythmic drugs
- Left atrium size less than 55 mm, volume less than 130 ml, and 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 surgery
- Any previous heart intervention including MAZE surgery, thoracoscopic ablation, or implanted left atrial occluder
- Severe other medical conditions requiring treatment
- Contraindications to anticoagulant therapy
- Blood clot in the left atrium or other reasons preventing catheter insertion
- Body mass index (BMI) of 40 or more
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to the day of catheter ablation
Participants undergo radiofrequency pulmonary vein isolation. Some participants will have electrical cardioversion before the isolation procedure depending on their atrial fibrillation duration and heart ultrasound results.
1 procedure visit (in-person)
Follow-up
Duration - 12 months
Participants have echocardiographic assessments and 24-hour ECG monitoring to evaluate heart function and rhythm at 3, 6, and 12 months after the intervention. Quality of life questionnaires are also completed during these follow-up visits.
3 visits (in-person) at 3, 6, and 12 months post-treatment
Trial Site Locations
Total: 1 location
1
Saint Petersburg State University Clinic
Saint Petersburg, Sankt-Peterburg, Russia, 190020
Actively Recruiting
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Research Team
A
Anton A Sheremet, MD
A
Aleksei A Filippov, MD, PhD
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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Published Research Related To This Trial
Prediction of long-term outcomes of catheter ablation of persistent atrial fibrillation by parameters of preablation DC cardioversion.
Jun Hyuk Kang, Dae In Lee, Sua Kim...
https://pubmed.ncbi.nlm.nih.gov/22882453Late recurrence of atrial fibrillation 5 years after catheter ablation: predictors and outcome.
Sung Hwa Choi, Hee Tae Yu, Daehoon Kim...
https://pubmed.ncbi.nlm.nih.gov/37099677Preprocedural restoration of sinus rhythm and left atrial strain predict outcomes of catheter ablation for long-standing persistent atrial fibrillation.
Yuichi Hanaki, Tomoko Machino-Ohtsuka, Kazutaka Aonuma...
https://pubmed.ncbi.nlm.nih.gov/32391641Echocardiographic predictors of atrial fibrillation recurrence after catheter ablation: A literature review.
Aleksandra Liżewska-Springer, Alicja Dąbrowska-Kugacka, Ewa Lewicka...
https://pubmed.ncbi.nlm.nih.gov/29924375