NCT06654401 Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm
| NCT ID | NCT06654401 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Saint Petersburg State University, Russia |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 125 participants in total. It began in 2024-11-01 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Informed consent signed by the patient to participate in the study. * Persistent atrial fibrillation resistant to antiarrhythmic drugs for 6 months or more * The size of the left atrium is less than 55 mm, volume is less than 130 ml, volume index (LP) is less than 55 ml/m2 Exclusion Criteria: * Reversible causes of atrial fibrillation (hyperthyroidism, pericarditis, myocarditis). * Patients in need of myocardial revascularization and/or heart valvular disease correction. * Any previous intervention (including MAZE surgery, thoracoscopic ablation; implanted occluder of the auricle of the left atrium.). * Patients with severe concomitant pathology requiring correction. * Contraindications for administration of anticoagulant therapy. * Documented presence of a blood clot in the cavity of the left atrium or other reasons preventing the insertion of catheters into the left atrium. * BMI of 40 or more
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06654401 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06654401 currently recruiting?
Yes, NCT06654401 is actively recruiting participants. Contact the research team at sheremet.dr@yandex.ru for enrollment information.
Where is the NCT06654401 trial being conducted?
This trial is being conducted at Saint Petersburg, Russia.
Who is sponsoring the NCT06654401 clinical trial?
NCT06654401 is sponsored by Saint Petersburg State University, Russia. The trial plans to enroll 125 participants.
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