Very high-power short-duration vs standard low-power radiofrequency ablation for atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label study compares two radiofrequency ablation strategies for pulmonary vein isolation in adults with paroxysmal or persistent atrial fibrillation. Participants are assigned to either very high-power short-duration ablation at 90 W or conventional low-power ablation at 35-45 W, using non-fluoroscopic navigation and CLOSE protocol. The trial targets experienced AF centers and plans to enroll 196 patients. Outcomes focus on safety and efficacy of the energy delivery strategies in achieving durable isolation. The study excludes patients with significant comorbidities or organ dysfunction that could confound results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age over 18 years old;
* Atrial fibrillation resistant to antiarrhythmic therapy;
* Paroxysmal form of atrial fibrillation;
* Persistent form of atrial fibrillation;
* The patient's consent to participate in the study.

Exclusion Criteria:

Exclusion Criteria:

* Age under 18 and over 80 years old;
* The presence of another cardiac pathology requiring surgical treatment;
* Congenital heart defects;
* Previous "open" cardiac surgery;
* Bone marrow diseases;
* Pathology of the blood coagulation system;
* The left ventricular ejection fraction is less than 40%;
* Moderate to severe renal insufficiency (creatinine clearance \<50 ml/min);
* Drug-resistant hypertension (despite hypotensive therapy);
* Organically altered mitral valve;
* There are reasons to assume that the patient will not show up for subsequent visits (control points of the study) for various reasons;
* The patient's participation in another clinical trial.

Where it's running

• Bakulev National Medical Research Center for Cardiovascular Surgery
  Moscow, Russia Recruiting

Study contacts

• Principal investigator: Andrey Filatov — Bakulev Scientific Center for Cardiovascular Surgery
• Study coordinator: Andrey Filatov
• Email: agfilatov@bakulev.ru
• Phone: +7(495) 414-77-02

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.