The Outcomes of Sympathetic Cardiac Denervation on Postoperative Atrial Fibrillation After Cardiac Surgery, Randomized Controlled Trial

NCT07811817 | Active Not Recruiting DMC

• 1 other identifier: ZU-IRB #1782/19-10-2025
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

we compare the effect of cutting heart nerves in one group of patients with open heart surgery and other group without cutting oh development of disturbance of heart beat after surgery

Conditions

Post Cardiac Surgery Atrial Fibrillation

Keywords

sympathetic cardiac denervation; post cardiac surgery atrial fibrillation

Outcome Measures

Primary Outcomes (2)

• Incidence of overall Post operative atrial fibrillation

  defined as any telemetry-documented or 12-lead ECG-confirmed episode of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 continuous seconds through POD 7 or hospital discharge defined as any telemetry-documented or 12-lead ECG-confirmed episode of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 continuous seconds through POD 7 or hospital discharge (whichever comes first

  7th Post operative day or hospital discharge (whichever comes first).

• Incidence of persistent Post operative atrial fibrillation

  (duration \>24 continuous hours or requiring urgent chemical/electrical cardioversion due to hemodynamic instability).

  3 months posoperative

Study Arms (2)

sympathetic cardiac denervation

ACTIVE COMPARATOR

Before CPB initiation or during aortic cross-clamping, surgical denervation will be performed via meticulous blunt and sharp dissection. Target sites include \[e.g., complete transection/resection of the ligament of Marshall, fat pad mobilization at Waterston's groove, and epicardial neural pathway division\].

Procedure: cardiac sympathetic denervation

control

OTHER

Standard open-heart surgery without additional epicardial or fat pad dissection.

Procedure: Standard open-heart surgery without additional epicardial or fat pad dissection.

Interventions

cardiac sympathetic denervation PROCEDURE

Before CPB initiation or during aortic cross-clamping, surgical denervation will be performed via meticulous blunt and sharp dissection. Target sites include \[e.g., complete transection/resection of the ligament of Marshall, fat pad mobilization at Waterston's groove, and epicardial neural pathway division\].

sympathetic cardiac denervation

Standard open-heart surgery without additional epicardial or fat pad dissection. PROCEDURE

Standard open-heart surgery without additional epicardial or fat pad dissection.

control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years scheduled for elective open-heart surgery via median sternotomy (CABG, valve repair/replacement, or combined procedures).

You may not qualify if:

• Preoperative permanent pacemaker or ICD.
• Emergency surgery, active endocarditis, or severe hemodynamic instability.
• Concomitant planned surgical ablation (e.g., Cox-Maze procedure) or left atrial appendage occlusion.
• Preoperative use of antiarrhythmic drugs (AADs) other than beta-blockers within 5 half-lives of surgery.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Amr Tawfek

Zagazig, Sharqia Province, 44519, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of cardiothoracic surgery

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: October 20, 2025
• Primary Completion: September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)