Left Atrial Cryoablation Enhanced by Ganglionated Plexi Ablation in the Treatment of Atrial Fibrillation

Not Applicable

Completed

• Conditions: Tricuspid Valve Disease; Aortic Valve Disease; Mitral Valve Disease; Coronary Artery Disease; Atrial Fibrillation
• Interventions: Procedure: No intervention; Procedure: Concomitant Mapping and Radiofrequency Ablation

• Registration Number: NCT03239262
• Lead Sponsor: University Hospital Ostrava

Brief Summary

The aim of our study was to investigate, whether enhancement of left atrial cryoablation by ablation of the autonomic nervous system of left atrium leads to influencing the outcomes of surgical treatment of atrial fibrillation in patients with structural heart disease undergoing open-heart surgery.

Detailed Description

The observed patient file consisted of 100 patients, who have undergone a combined open-heart surgery at our department between July 2012 and December 2014. The patients were indicated for the surgical procedure due to structural heart disease, and suffered from paroxysmal, persistent, or long-standing persistent atrial fibrillation. In all cases, left atrial cryoablation was performed in the extent of isolation of pulmonary veins, box lesion, connecting lesion with mitral annulus, amputation of the left atrial appendage and connecting lesion of the appendage base with left pulmonary veins. Furthermore, thirty-five of the patients underwent mapping and radiofrequency ablation of ganglionated plexi, together with decision and ablation of the ligament of Marshall.

Study Timeline

• Study Start: 2012-07-01
• Primary Completion: 2016-01-31
• Study Completion: 2016-02-28
• Status Verified: 2017-07
• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-07-31
• Last Update Submitted: 2017-07-31
• Study First Posted: 2017-08-04
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Indication for open-heart surgery (mitral valve disease and/or tricuspidal valve disease and/or aortic valve disease and/or coronary artery disease and/or other)
• Concomitant paroxysmal, persistent, long standing persistent atrial fibrillation
• Signing of the informed consent

Exclusion Criteria

• Age below 40 and over 80 years of age
• Left ventricular ejection fraction below 25%
• Left atrium diameter over 60mm
• Permanent atrial fibrillation
• Polymorbidity (Euroscore II over 10)
• Emergency surgery
• Renal insufficiency (creatinine over 200 umol/l)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group LA	No intervention	Sixty five patients (65%) in whom no intervention related to ganglionated plexi was performed (Group LA).
Group GP	Concomitant Mapping and Radiofrequency Ablation	Thirty-five patients (35%) from our population underwent concomitant mapping and radiofrequency ablation of ganglionated plexi (Group GP).

Primary Outcome Measures

Name	Time	Method
Sinus Rhythm	30 months	The primary outcome was establishment and duration of sinus rhythm in the course of one-year follow-up.

Secondary Outcome Measures

Name	Time	Method
Recurrence of Atrial Fibrillation and the Presence of a Mitral Valve Surgery	30 months	The secondary outcome was the detection of relationship between the recurrence of atrial fibrillation and the presence of a mitral valve surgery, the presence of a mitral and tricuspid valves surgery and the left atrium diameter \>50 mm.