Postoperative Atrial FibrillationPROBOXNCT06823778
Prophylactic Radiofrequency Left Atrial Posterior Wall Isolation to Prevent Atrial Fibrillation After Cardiac Surgery
A study testing Radiofrequency ablation in people with Postoperative Atrial Fibrillation, run by Vasily I. Kaleda at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Atrial Fibrillation
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteRussia
- Study dates
- 17 Feb 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing cardiac surgery by a single surgeon (V.K.)
- Informed consent
Who cannot join
- History of atrial fibrillation/flutter
- Minimally invasive approach
- Off-pump surgery
- Emergent/salvage surgery
- Severe pericardial adhesions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Department of Cardiac Surgery, Yudin Hospital
Moscow, Moscow, 115446
Vasily I. Kaleda, M.D., Ph.D., 7 (985) 641 1769, vasily.kaleda@gmail.com
About this study
Official title: Prophylactic Radiofrequency Left Atrial Posterior Wall Isolation (box Lesion Ablation) to Prevent Atrial Fibrillation After Cardiac Surgery (PROBOX): a Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
Postoperative atrial fibrillation (POAF) is a common complication after heart surgery that occurs in 10-60% of patients. It can cause hypotension, tachycardia, stroke, systemic embolism, or heart failure, and is associated with increased mortality rates, prolonged hospital stays and increased costs. Several studies have investigated the use of radiofrequency ablation (the standard of surgical care for atrial fibrillation during concomitant cardiac surgery when the diagnosis is known preoperatively) to prevent POAF. However, these studies were limited mainly to pulmonary vein isolation and had methodological limitations such as small sample sizes, inclusion/exclusion criteria, and randomization procedures, and have not translated into clinical practice changes. The current study aims to investigate the use of radiofrequency left atrial posterior wall isolation, also known as box lesion ablation, as a more effective treatment compared to pulmonary vein isolation, in a properly designed randomized controlled trial.
- Conditions
- Postoperative Atrial Fibrillation
- Being tested
- Radiofrequency ablation
- Keywords
- Postoperative Atrial Fibrillation, Radiofrequency Ablation, Box Lesion Ablation, Prophylactic Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationDevice
In this group of patients, epicardial radiofrequency left atrial posterior wall isolation will be performed with AtriCure Isolator Synergy OLL2 bipolar radiofrequency clamp without opening the left atrium.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No ablation will be performed in this group of patients. |
| Intervention | Experimental | In this group of patients, radiofrequency left atrial posterior wall isolation will be performed. Receives: Device: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Atrial Fibrillation
Incidence of clinically significant (requiring any type of intervention) postoperative atrial fibrillation
Measured: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery
Secondary outcomes (4)
Postoperative Mortality
All deaths occurring during the hospitalization in which the operation was performed, even if after 30 days; and all deaths occurring after discharge from the hospital, but before the end of the 30th postoperative day.
Measured: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery
Postoperative Stroke
Number of patients who have a postoperative stroke (i.e., any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain) that did not resolve within 24 hours
Measured: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery
Length of Stay
Postoperative length of in-hospital stay
Measured: Up to 6 months after surgery
Unplanned Readmission
Unplanned 30-day any cause readmission rate
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start17 Feb 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Prospective Parallel-Arm Single-Blind Randomized Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vasily I. Kaleda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vasily I. Kaleda, Yudin Hospital
- Investigators
- Alexandr Piskun, M.D., Ph.D., Study chair, Yudin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823778
- Sponsor's protocol ID
- 1.2025
- Acronym
- PROBOX
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Visanji M, Belley-Cote EP, Pandey A, Amit Y, McClure GR, Young J, Um KJ, Oraii A, Healey JS, Whitlock RP, McIntyre WF. Prophylactic ablation during cardiac surgery in patients without atrial fibrillation: a systematic review and meta-analysis of randomized trials. Interdiscip Cardiovasc Thorac Surg. 2024 Dec 3;39(6):ivae195. doi: 10.1093/icvts/ivae195.
PubMed 39589863Kaleda VI, Snegirev MA, Efendiev VU, Piskun AV, Batukov IA, Nazaryan KE, Pidanov OY. Concomitant Box Lesion Ablation for Atrial Fibrillation with a Standard Non-Irrigated Bipolar Radiofrequency Clamp: Simplified Approach Without Left Atriotomy. Braz J Cardiovasc Surg. 2025 Feb 17;40(2):e20230432. doi: 10.21470/1678-9741-2023-0432.
PubMed 39960384
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Radiofrequency Left Atrial Posterior Wall Isolation (box Lesion Ablation) to Prevent Atrial Fibrillation After Cardiac Surgery (PROBOX): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06823778
- Acronym / sponsor ID
- PROBOX / 1.2025
- Conditions
- Postoperative Atrial Fibrillation
- Keywords
- Postoperative Atrial Fibrillation, Radiofrequency Ablation, Box Lesion Ablation, Prophylactic Ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Vasily I. KaledaUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postoperative atrial fibrillation (POAF) is a common complication after heart surgery that occurs in 10-60% of patients. It can cause hypotension, tachycardia, stroke, systemic embolism, or heart failure, and is associated with increased mortality rates, prolonged hospital stays and increased costs. Several studies have investigated the use of radiofrequency ablation (the standard of surgical care for atrial fibrillation during concomitant cardiac surgery when the diagnosis is known preoperatively) to prevent POAF. However, these studies were limited mainly to pulmonary vein isolation and had methodological limitations such as small sample sizes, inclusion/exclusion criteria, and randomization procedures, and have not translated into clinical practice changes. The current study aims to investigate the use of radiofrequency left atrial posterior wall isolation, also known as box lesion ablation, as a more effective treatment compared to pulmonary vein isolation, in a properly designed randomized controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A Prospective Parallel-Arm Single-Blind Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No ablation will be performed in this group of patients. |
| Intervention | Experimental | Device: Radiofrequency ablationIn this group of patients, radiofrequency left atrial posterior wall isolation will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients undergoing cardiac surgery by a single surgeon (V.K.)
- Informed consent
Key exclusion criteria (5 listed)
- History of atrial fibrillation/flutter
- Minimally invasive approach
- Off-pump surgery
- Emergent/salvage surgery
- Severe pericardial adhesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablationIn this group of patients, epicardial radiofrequency left atrial posterior wall isolation will be performed with AtriCure Isolator Synergy OLL2 bipolar radiofrequency clamp without opening the left atrium. | Device | Intervention |
Primary outcome
Postoperative Atrial Fibrillation
Time frame: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery
Incidence of clinically significant (requiring any type of intervention) postoperative atrial fibrillation
4 secondary outcomes
Postoperative Mortality
Time frame: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery
Postoperative Stroke
Time frame: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery
Length of Stay
Time frame: Up to 6 months after surgery
Unplanned Readmission
Time frame: Within 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Background: PubMed 39589863Visanji M, Belley-Cote EP, Pandey A, Amit Y, McClure GR, Young J, Um KJ, Oraii A, Healey JS, Whitlock RP, McIntyre WF. Prophylactic ablation during cardiac surgery in patients without atrial fibrillation: a systematic review and meta-analysis of randomized trials. Interdiscip Cardiovasc Thorac Surg. 2024 Dec 3;39(6):ivae195. doi: 10.1093/icvts/ivae195.
- Background: PubMed 39960384Kaleda VI, Snegirev MA, Efendiev VU, Piskun AV, Batukov IA, Nazaryan KE, Pidanov OY. Concomitant Box Lesion Ablation for Atrial Fibrillation with a Standard Non-Irrigated Bipolar Radiofrequency Clamp: Simplified Approach Without Left Atriotomy. Braz J Cardiovasc Surg. 2025 Feb 17;40(2):e20230432. doi: 10.21470/1678-9741-2023-0432.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandr Piskun, M.D., Ph.D. study chair
Yudin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation in people with Postoperative Atrial Fibrillation, run by Vasily I. Kaleda at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vasily I. Kaleda, M.D., Ph.D. (7 (985) 641 1769, vasily.kaleda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Atrial Fibrillation (time frame: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06823778, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.