Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial Fibrillation (AF) with the Cardioblate CryoFlex Surgical Ablation System. The system is approved and commercially available with CE mark. The purpose of this study is to support clinical evidence that the Cardioblate System is safe and effective to treat AF.
Introduction: Among the cardiac arrhythmias, Atrial Fibrillation (AF) is the most common sustained cardiac arrhythmia in the general population and represents an increasing problem worldwide. Management strategies for AF include combinations of various treatments, including surgery. Cox et al. developed the surgical Maze procedure to restore sinus conduction to the AV node and to restore effective, synchronized bi-atrial contraction. In an effort to address the observed challenges and make this treatment available to more subjects, modifications of the Maze pattern and new lesion patterns have being developed and tested. Devices using new technologies, like cryothermia, were developed in an effort to reduce the time required to make the lesion pattern.The Cardioblate® CryoFlex™ Surgical Ablation System has been successfully used for the surgical ablation of cardiac arrhythmias including atrial fibrillation. The system utilizes cryothermia to create the linear lesions of the surgical Maze-III procedure. Purpose: To provide clinical evidence showing that the Cox Cryo Maze III procedure is effective and safe in subjects with longstanding persistent AF undergoing mitral valve repair or replacement. Study objective: The study objectives were to characterize the safety and efficacy of the Medtronic Cardioblate CryoFlex Surgical Ablation System when used to treat subjects with longstanding persistent AF requiring concomitant mitral valve repair or replacement.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Longstanding persistent AF was treated with the Cox Cryo Maze III procedure During mitral valve surgery a surgical ablation was performed, using the Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
Classic mitral valve surgery was performed
During the procedure, a Medtronic Reveal XT Insertable Cardiac Monitor was implanted to monitor episodes of AF during follow-up period
Herzzentrum Leipzig GmbH
Leipzig, Germany
Sheba Medical Center
Tel Litwinsky, Israel
San Raffaele Hospital
Milan, Italy
Hospital Clinic de Barcelona
Barcelona, Spain
Efficacy: Percentage of Treated Subjects Diagnosed With Longstanding Persistent AF Off Class I or III Antiarrhythmic Drugs and Out of AF at 12 Months, and Who Did Not Receive Additional Ablation Therapy for AF Prior to the 12-month Evaluation.
The primary efficacy endpoint was defined as the percentage of subjects diagnosed with longstanding persistent AF off Class I or III antiarrhythmic drugs and out of AF, as determined by Reveal XT recordings (AF burden \< 0.5% per 24h) at 12 months and who did not receive additional ablation therapy for AF prior to the 12-month evaluation. An additional ablation therapy could include percutaneous catheter ablation or AV nodal ablation (cauterizing or freezing the AV node). Cardioversions were allowed only during the 12 week blanking period.
Time frame: 12 months
Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last
The composite MAE was defined as a subject experiencing any of the following adverse events: * Stroke * Transient ischemic attack (TIA) * Pulmonary embolism * Peripheral arterial embolism * Myocardial infarction (MI) * Mediastinitis * Esophageal injury * Death * Cardiac injury related to the use of the Cardioblate CryoFlex System that required additional surgical or catheter intervention
Time frame: 30 days
Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs
Time frame: 12 Months
Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs
Time frame: 3 Months
Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs
Time frame: 6 Months
AF Burden in Subjects Diagnosed With Longstanding Persistent AF as Measured by Reveal XT Recordings at 3, 6 and 12 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Enrollment
17
Longstanding persistent AF was treated with the Cox Cryo Maze III procedure
AF burden is defined as percentage of time the patient is in AF during 24 hours.
Time frame: 3, 6 and 12 Months
Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure
The 12-Item Short Form Health Survey (SF-12) is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Ten summary scores are reported from the SF-12. The scale range for each of the ten subscales is from 0 to 100, with higher scores corresponding to a better outcome. Subjects average unit score (with standard deviation) are reported at baseline, 6 and 12 months. As unit of measure we used units on a scale.
Time frame: 6 and 12 months
Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last
The composite MAE was defined as a subject experiencing any of the following adverse events: * Stroke * Transient ischemic attack (TIA) * Pulmonary embolism * Peripheral arterial embolism * Myocardial infarction (MI) * Mediastinitis * Esophageal injury * Death * Cardiac injury related to the use of the Cardioblate CryoFlex System that required additional surgical or catheter intervention
Time frame: 12 months