Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Subjects With Longstanding Persistent Atrial Fibrillation Requiring Mitral Valve Surgery
|ClinicalTrials.gov Identifier: NCT01558635|
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : May 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Longstanding Persistent Atrial Fibrillation||Device: Maze III procedure with Cardioblate CryoFlex Surgical Ablation System||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cryo-AF Clinical Study|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Experimental: Cardioblate CryoFlex Surgical Ablation
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to Mitral valve surgery
Device: Maze III procedure with Cardioblate CryoFlex Surgical Ablation System
During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
- 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. [ Time Frame: 12 months ]
- Safety: the rate of device and procedure related acute major adverse events (MAE) within 30 days post-procedure or prior to hospital discharge, whichever came last. [ Time Frame: 30 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558635
|Herzzentrum Leipzig GmbH|
|Sheba Medical Center|
|San Raffaele Hospital|
|Milan, Italy, 20149|
|Hospital Clinic de Barcelona|