European CURE-AF Study

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04645615
• Other study ID #: European CURE-AF Study
• Status: Completed
• Phase: N/A
• Start date: June 19, 2008
• Est. completion date: July 10, 2013

Study information

• Verified date: November 2020
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 10, 2013
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must meet all of the following criteria to be enrolled in the study:

1. Documented history of AF a For inclusion in permanent AF arm: Patients must have a documented history of permanent AF (cardioversion failure) as defined by the ACC/AHA/ESC Guidelines; Documentation of AF must include one or more chart references to AF and/or one or more ECG's with AF prior to the patient's surgery. Other supporting information could include references to cardioversion attempts using either drugs or electrical shock. b For inclusion in persistent AF arm: Patients must have a documented history of persistent AF as defined by the ACC/AHA/ESC Guidelines: characterized as episodes of non-self-terminating atrial fibrillation that usually lasts more than 7 days

2. Concomitant indication (other than AF) for open-heart surgery for one or more of the following:

a Mitral valve repair or replacement, b Aortic valve repair or replacement, c Tricuspid valve repair or replacement, d ASD repair, e PFO closure, or f CABG procedures; 3 Able to take the anticoagulant warfarin or other ACC/AHA/ESC-recommended anticoagulant medication; 4 Greater than or equal to 18 years of age; 5 Able and willing to comply with study requirements by signing a Patient Informed Consent form.

Exclusion Criteria:

• Patients who meet any of the following criteria may not be enrolled in the study:

1 Wolff-Parkinson-White syndrome, 2 NYHA functional class = IV, 3 Left ventricular ejection fraction = 30%, 4 Left atrial diameter > 7.0 cm, 5. Need for emergent cardiac surgery (i.e. cardiogenic shock) or redo open heart surgery, 6 Preoperative need for an intra-aortic balloon pump or intravenous inotropes, 7 Previous atrial ablation, AV-nodal ablation, or surgical Maze procedure, 8 Contraindication for anticoagulation therapy, 9 Current diagnosis of active systemic infection, 10 Renal failure requiring dialysis or hepatic failure, 11 Documented myocardial infarction 6 weeks prior to study enrollment, 12 Life expectancy of less than one year, or 13 Pregnancy or desire to be pregnant within 12-months of the study treatment.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Germany	Kerckhoff Clinic - Department of Thoracic & Cardiovascular Surgery	Bad Nauheim	Beneke Str. 2-8
Germany	Heart Center Cottbus - Department of Cardiac Surgery	Cottbus	Leipziger Strasse 50
Norway	Haukeland University Hospital - Department of Cardiothoracic Surgery	Bergen	Jonas Liesvei 65
Norway	St. Elizabeth Heart Center - Department of Cardiothoracic Surgery	Trondheim	Hans Nissens Gate 3
Poland	Public Central Teaching Hospital - Department of Cardiac Surgery	Warsaw	Ul. Banacha 1a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

Germany,  Norway,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Permanent AF Arm	Primary efficacy endpoint- The percent of patients free of AF, off Class I or III antiarrhythmic drugs and not having received additional ablation therapy, as determined by a 24-hour Holter recording at 6 months follow-up.	24-hour Holter recording at 6 months follow-up
Primary	Persistent AF Arm	The percent of patients free of AF, off Class I or III antiarrhythmic drugs and not having received additional ablation therapy, as determined by a 24-hour Holter recording at 9 months follow-up.	24-hour Holter recording at 9 months follow-up.
Secondary	Permanent AF Arm	Secondary efficacy endpoints - 24-hour Holter recording, b) improvement in left ventricular ejection fraction and c) left atrial transport function as evidenced by the presence of an A wave at 6 months follow-up.	24 hours
Secondary	Persistent AF Arm	Secondary efficacy endpoints - a) The percent of patients free of AF, regardless of Class I or III antiarrhythmic drug use and not having received additional ablation therapy, as determined by a 24-hour Holter recording, b) improvement in left ventricular ejection fraction and c) left atrial transport function as evidenced by the presence of an A wave at 9 months follow-up.	24-hour Holter recording at 9 months follow-up.