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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03239262
Enrollment
100
Registered
2017-08-04
Start date
2012-07-01
Completion date
2016-02-28
Last updated
2017-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Atrial Fibrillation, Coronary Artery Disease, Mitral Valve Disease, Tricuspid Valve Disease

Keywords

Atrial Fibrillation, Left Atrial Cryoablation, Ganglionated Plexi, Open-Heart Surgery

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.

Interventions

PROCEDUREConcomitant 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.

PROCEDURENo intervention

No intervention was performed in patients without ganglionated plexi.

Sponsors

University Hospital Ostrava
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Sinus Rhythm30 monthsThe primary outcome was establishment and duration of sinus rhythm in the course of one-year follow-up.

Secondary

MeasureTime frameDescription
Recurrence of Atrial Fibrillation and the Presence of a Mitral Valve Surgery30 monthsThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026