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

NCT06823778 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2025-02-21

No results posted yet for this study

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. 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.

Conditions

  • Postoperative Atrial Fibrillation

Interventions

DEVICE

Radiofrequency ablation

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.

Sponsors & Collaborators

  • Vasily I. Kaleda

    lead OTHER

Principal Investigators

  • Alexandr Piskun, M.D., Ph.D. · Yudin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-17
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Device
Yes

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06823778 on ClinicalTrials.gov