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NCT Number: NCT06654401

Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation, Persistent Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Petersburg State University Clinic

Saint Petersburg, Sankt-Peterburg, 190020, Russia

Location status: Recruiting

Location contact

Sergei M Efremov, MD, PhD

CONTACT

[email protected]

+79137946090

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transthoracic echocardiography

Diagnostic Test

Standard assessment of the parameters of the left atrium: size, volume, volume indices

24-hour ECG Monitor

Diagnostic Test

Assessment of cardiac arrhythmias according to 24-hour monitoring data

Electroanatomic mapping

Procedure

Intraoperative assessment of low voltage areas (potential fibrosis zones)

Primary outcomes

  1. Freedom from atrial fibrillation 6 months after catheter ablation

    Time frame: Echocardiographic assessment of the parameters of the left atrium and 24-hour ECG monitoring is performed at the time of admission to the hospital; after 3,6 and 12 months after intervention or the latest data in the event of death, whenever comes first

    Absence of events of sustained atrial tachycardia according to 24-hour ECG monitoring

Secondary outcomes

  1. Reverse remodeling of the left atrium and improvement of the contractility of the left ventricle

    Time frame: Echocardiographic assessment of the parameters of the left atrium and 24-hour ECG monitoring is performed at the time of admission to the hospital; after 3,6 and 12 months after intervention or the latest data in the event of death, whenever comes first

    An increase in the LV ejection fraction, a decrease in the volume and size of the left atrium according to transthoracic echocardiography

  2. Freedom from atrial fibrillation 12 months after catheter ablation

    Time frame: Echocardiographic assessment of the parameters of the left atrium and 24-hour ECG monitoring is performed at the time of admission to the hospital; after 3,6 and 12 months after intervention or the latest data in the event of death, whenever comes first

    Absence of events of sustained atrial tachycardia according to 24-hour monitoring

  3. Improving the quality of life of patients with atrial fibrillation

    Time frame: Patients fill out questionnaires upon admission to the hospital; 3, 6 and 12 months after surgical treatment or the latest data in the event of death, whenever comes first

    Assessment of the quality of life of patients with atrial fibrillation based on a questionnaire:

    Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire - provides an overall score; plus scores for symptoms, daily activities, treatment concerns, and treatment satisfaction.

    Overall or subscale scores range from 0-100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered).

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksei A Filippov, MD, PhD

CONTACT

[email protected]

+79819553639

Anton A Sheremet, MD

CONTACT

[email protected]

+79313084398

Sponsors and collaborators

Lead sponsor

Saint Petersburg State University, Russia

Other

Registry information

Official study title

Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm in Patients with Persistent Atrial Fibrillation Before Radio Frequency Pulmonary Vein Isolation

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 23, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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