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Completed

NCT Number: NCT03239262

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

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.

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Key information

Conditions

Mitral Valve Disease Aortic Valve Disease Arrhythmias, Cardiac Arterial Occlusive Diseases Arteriosclerosis Atrial Fibrillation Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Tricuspid Valve Disease Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Concomitant Mapping and Radiofrequency Ablation

Procedure

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.

No intervention

Procedure

No intervention was performed in patients without ganglionated plexi.

Primary outcomes

  1. Sinus Rhythm

    Time frame: 30 months

    The primary outcome was establishment and duration of sinus rhythm in the course of one-year follow-up.

Secondary outcomes

  1. Recurrence of Atrial Fibrillation and the Presence of a Mitral Valve Surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 4, 2017
Registry last updated
Aug 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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