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

N/AActive Not RecruitingNCT07811817

Zagazig University560 enrolled

Overview

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

identifying the outcome of sympathetic denervation on postoperative atrial fibrillation post cardiac surgery

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

560

Conditions

Post Cardiac Surgery Atrial Fibrillation

Interventions

cardiac sympathetic denervationPROCEDURE

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

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: Age ≥18 years scheduled for elective open-heart surgery via median sternotomy (CABG, valve repair/replacement, or combined procedures). \- Exclusion Criteria: * 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.

Locations (1)

Amr Tawfek

Zagazig, Sharqia Province, Egypt

Outcomes

Primary Outcomes

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

Time frame: 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).

Time frame: 3 months posoperative

Data from ClinicalTrials.gov

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