NCT01558635

Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation

Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Subjects With Longstanding Persistent Atrial Fibrillation Requiring Mitral Valve Surgery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Longstanding Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Cardioblate CryoFlex Surgical Ablation	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.
PROCEDURE	Mitral Valve surgery	Classic mitral valve surgery was performed
DEVICE	Medtronic Reveal XT Insertable Cardiac Monitor	During the procedure, a Medtronic Reveal XT Insertable Cardiac Monitor was implanted to monitor episodes of AF during follow-up period
PROCEDURE	MAZE III	Longstanding persistent AF was treated with the Cox Cryo Maze III procedure

Timeline

• Start date: 2011-11-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2012-03-20
• Last updated: 2019-07-30
• Results posted: 2019-03-01

Locations

4 sites across 4 countries: Germany, Israel, Italy, Spain