NCT04645615

European CURE-AF Study

European CURE-AF Study - Concomitant Utilization of Radiofrequency Energy for Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, non-randomized, multi-center clinical trial. The patient population includes patients with permanent or persistent AF requiring valve replacements or repairs, ASD repairs, PFO closure or coronary artery bypass grafts (CABG) procedures. Patients are not allowed to have had previous atrial ablation, AV-nodal ablation, or surgical Maze procedure.

Detailed description

The Cardioblate Surgical Ablation System is cleared in Canada and Europe for ablation of cardiac tissue for the treatment of cardiac arrhythmias. In the United States, the Cardioblate bipolar is approved for soft tissue ablation, while the Cardioblate Pen is approved for cardiac tissue ablation. The purpose of the clinical study is to obtain a labeling claim for the US market that the Cardioblate Surgical Ablation System can be used for ablation of cardiac tissue in the treatment of cardiac arrhythmias such as atrial fibrillation among permanent and persistent AF patients.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Cardioblate surgical ablation system	This investigation is a prospective, non-randomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.
PROCEDURE	Surgical RF Ablation	This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.

Timeline

• Start date: 2008-06-19
• Primary completion: 2011-02-01
• Completion: 2013-07-10
• First posted: 2020-11-27
• Last updated: 2020-11-27

Locations

5 sites across 3 countries: Germany, Norway, Poland