Prospective, multi-center, investigator-driven trial. This study hypothesizes that combining surgical endoscopic and transcatheter techniques in a staged fashion provides superior clinical outcomes than isolated surgical/EP approaches in patients with persistent AF lasting \> 1 year but \> 5 years. The proposed procedure involves the creation of cardiac lesions with epicardially applied radiofrequency (RF) ablation through a minimally invasive surgical (MIS) approach followed by a delayed EP ablation procedure performed at 1-2 months from the surgical operation.
New ablative technologies have been developed to simplify the original "cut and sew" Cox Maze procedure so that it can now be used for routine treatment of AF in patients undergoing open-heart surgery, as well as in a stand-alone arrhythmia procedure. A minimally invasive, thoracoscopic surgical treatment of AF is able to address both the triggers for AF by pulmonary vein isolation and the left posterior atrial wall exclusion, which after the pulmonary veins is the next most important atrial substrate in the promotion of AF. New hybrid procedures attempt to combine the success rate and the minimally invasive nature of thoracoscopic mini-Maze with the effectiveness and short recovery times associated with catheter ablation. The key is blocking signals that cause the arrhythmia from both outside (epicardial) and inside (endocardial) the heart. Suboptimal results of both catheter ablation and surgery suggest that success in the treatment of long standing persistent AF and persistent lone AF will benefit from a close collaboration between the cardiothoracic surgeon and the electrophysiologist, to offer patients the best available combination of treatments for any given set of cardiovascular lesions. Hybrid treatment for AF is being increasingly adopted in Europe and the United States and has been assessed for the treatment of AF at the Coordinating Center (Brescia, Italy) with promising results.
Study Type
OBSERVATIONAL
Enrollment
100
Louis Pradel Hospital
Lyon, France
NOT_YET_RECRUITINGHeart Center Brandenburg- Immanuel
Bernau, Germany
NOT_YET_RECRUITINGStadtische Kliniken
Dortmund, Germany
NOT_YET_RECRUITINGHamburg Uke
Hamburg, Germany
NOT_YET_RECRUITINGOspedale Gavazzeni
Bergamo, Italy
NOT_YET_RECRUITINGUniv. Hosp. Spedali Civili
Brescia, Italy
RECRUITINGUniv.Hosp. Molinette
Torino, Italy
NOT_YET_RECRUITINGUniversity Hospital
Krakow, Poland
NOT_YET_RECRUITINGHammersmith Hospital
London, United Kingdom
NOT_YET_RECRUITINGRoyal Brompton
London, United Kingdom
NOT_YET_RECRUITINGPRIMARY EFFICACY ENDPOINT: 24-hour Holter monitoring
The primary efficacy endpoint is the rate of therapeutic success, with a target rate of \> 60%. Therapeutic success is defined as freedom from AF, during the 9 months following the end of the blanking period, based on 24-hour Holter monitor results, and freedom from AADs beginning at 6 months following surgery. The blanking period is 3 months following the surgical ablation procedure.
Time frame: 9 months following the end of the blanking period
SECONDARY EFFICACY ENDPOINTS: 24-hour Holter monitoring
Rate of therapeutic success is defined as freedom from AF, 9 months following the end of the blanking period, based on 24-hour Holter monitoring. The target success rate is \>60%. Rate of therapeutic success is defined as freedom from AF, during the 9 months following the end of the blanking period.The blanking period is 3 months following the surgical ablation procedure.
Time frame: 9 months following the end of the blanking period
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