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

Sponsor

University Hospital Ostrava (Other)

Overall Status

Completed

CT.gov ID

NCT03239262

Collaborator

(none)

100

Enrollment

Arms

43.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Disease Coronary Artery Disease Tricuspid Valve Disease Aortic Valve Disease Atrial Fibrillation	Procedure: Concomitant Mapping and Radiofrequency Ablation Procedure: No intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two groups of patients undergoing standard treatment have been compared retrospectively.Two groups of patients undergoing standard treatment have been compared retrospectively.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Assessment of the Effect of Left Atrial Cryoablation Enhanced by Ganglionated Plexi Ablation in the Treatment of Atrial Fibrillation in Patients Undergoing Open Heart Surgery

Actual Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Jan 31, 2016

Actual Study Completion Date :

Feb 28, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group GP Thirty-five patients (35%) from our population underwent concomitant mapping and radiofrequency ablation of ganglionated plexi (Group GP).	Procedure: Concomitant Mapping and Radiofrequency Ablation Mapping of GP around the orifice of pulmonary veins was performed, together with their radiofrequency ablation. In the area of right-side pulmonary veins, the procedure was performed prior to initiation of extracorporeal circulation. In case of the left-side PVs; the procedure was performed after initiation of extracorporeal circulation. Part of this procedure was also a decision and ablation of the ligament of Marshall. GP mapping was performed using high-frequency stimulation (1000 beats min-¹, potential 18V, pulse width 1.5ms). The indication for GP ablation was a doubling in the R-R interval in the sinus rhythm, or ventricular rate slowing of more that 50% associated with a decrease of blood pressure>20mmHg in patients with AF. In case of a positive response, radiofrequency ablation of the ganglia was performed following switching of the pen at the console. This procedure was repeated until the activity of the ganglia has disappeared.
Experimental: Group LA Sixty five patients (65%) in whom no intervention related to ganglionated plexi was performed (Group LA).	Procedure: No intervention No intervention was performed in patients without ganglionated plexi.

Arm

Intervention/Treatment

Experimental: Group GP

Thirty-five patients (35%) from our population underwent concomitant mapping and radiofrequency ablation of ganglionated plexi (Group GP).

Procedure: Concomitant Mapping and Radiofrequency Ablation

Mapping of GP around the orifice of pulmonary veins was performed, together with their radiofrequency ablation. In the area of right-side pulmonary veins, the procedure was performed prior to initiation of extracorporeal circulation. In case of the left-side PVs; the procedure was performed after initiation of extracorporeal circulation. Part of this procedure was also a decision and ablation of the ligament of Marshall. GP mapping was performed using high-frequency stimulation (1000 beats min-¹, potential 18V, pulse width 1.5ms). The indication for GP ablation was a doubling in the R-R interval in the sinus rhythm, or ventricular rate slowing of more that 50% associated with a decrease of blood pressure>20mmHg in patients with AF. In case of a positive response, radiofrequency ablation of the ganglia was performed following switching of the pen at the console. This procedure was repeated until the activity of the ganglia has disappeared.

Experimental: Group LA

Sixty five patients (65%) in whom no intervention related to ganglionated plexi was performed (Group LA).

Procedure: No intervention

No intervention was performed in patients without ganglionated plexi.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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