Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06654401

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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