Back to resultsEuropean CURE-AF Study
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cardioblate surgical ablation system
Surgical RF Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
Patients must meet all of the following criteria to be enrolled in the study:
- 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
- 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.
Sites / Locations
- Kerckhoff Clinic - Department of Thoracic & Cardiovascular Surgery
- Heart Center Cottbus - Department of Cardiac Surgery
- St. Elizabeth Heart Center - Department of Cardiothoracic Surgery
- Haukeland University Hospital - Department of Cardiothoracic Surgery
- Public Central Teaching Hospital - Department of Cardiac Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CURE AF
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04645615
First Posted
November 20, 2020
Last Updated
November 20, 2020
Sponsor
Medtronic Cardiovascular
1. Study Identification
Unique Protocol Identification Number
NCT04645615
Brief Title
European CURE-AF Study
Official Title
European CURE-AF Study - Concomitant Utilization of Radiofrequency Energy for Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 19, 2008 (Actual)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
July 10, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CURE AF
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Cardioblate surgical ablation system
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgical RF Ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Permanent AF Arm
Description
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.
Time Frame
24-hour Holter recording at 6 months follow-up
Title
Persistent AF Arm
Description
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.
Time Frame
24-hour Holter recording at 9 months follow-up.
Secondary Outcome Measure Information:
Title
Permanent AF Arm
Description
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.
Time Frame
24 hours
Title
Persistent AF Arm
Description
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.
Time Frame
24-hour Holter recording at 9 months follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must meet all of the following criteria to be enrolled in the study:
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
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.
Facility Information:
Facility Name
Kerckhoff Clinic - Department of Thoracic & Cardiovascular Surgery
City
Bad Nauheim
State/Province
Beneke Str. 2-8
ZIP/Postal Code
61231
Country
Germany
Facility Name
Heart Center Cottbus - Department of Cardiac Surgery
City
Cottbus
State/Province
Leipziger Strasse 50
ZIP/Postal Code
03048
Country
Germany
Facility Name
St. Elizabeth Heart Center - Department of Cardiothoracic Surgery
City
Trondheim
State/Province
Hans Nissens Gate 3
ZIP/Postal Code
7018
Country
Norway
Facility Name
Haukeland University Hospital - Department of Cardiothoracic Surgery
City
Bergen
State/Province
Jonas Liesvei 65
ZIP/Postal Code
5021
Country
Norway
Facility Name
Public Central Teaching Hospital - Department of Cardiac Surgery
City
Warsaw
State/Province
Ul. Banacha 1a
ZIP/Postal Code
02-097
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
European CURE-AF Study
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