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NCT06823778Recruiting

Prophylactic Radiofrequency Left Atrial Posterior Wall Isolation to Prevent Atrial Fibrillation After Cardiac Surgery

Prophylactic Radiofrequency Left Atrial Posterior Wall Isolation (box Lesion Ablation) to Prevent Atrial Fibrillation After Cardiac Surgery (PROBOX): a Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 21 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this clinical trial is to learn if an epicardial radiofrequency left atrial posterior wall isolation (box lesion ablation) prevents atrial fibrillation after cardiac surgery. The main question it aims to answer is: \- Does box lesion ablation lower the number of patients experiencing de-novo atrial fibrillation requiring any treatment after cardiac surgery? Researchers will compare box lesion ablation to no ablation to see if ablation prevents postoperative atrial fibrillation. Participants will undergo ablation or no ablation at the time of other cardiac surgery. Data will be collected while in hospital. Additional information will be collected on 30th day after surgery by telephone call or during a visit.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
216 (estimated)
First submitted
2 Feb 2025
Start date
17 Feb 2025
Primary completion date
Sept 2027
Lead sponsor
Vasily I. Kaleda
NCT number
NCT06823778

What you commit to

  • Study type: Interventional
  • Planned participants: 216
  • From 17 Feb 2025 to the primary completion date, Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Off-pump surgery
  • Emergent/salvage surgery

Other illness

  • History of atrial fibrillation/flutter

Other

  • Minimally invasive approach
  • Severe pericardial adhesions

Who the study is looking for

  • All patients undergoing cardiac surgery by a single surgeon (V.K.)
  • Informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Cardiac Surgery, Yudin Hospital
Coordinator of this site? Confirm its status
MoscowRussiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.