Clinical trial NCT04645615: European CURE-AF Study
Official title: European CURE-AF Study - Concomitant Utilization of Radiofrequency Energy for Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2020-11-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Permanent AF Arm
timeFrame: 24-hour Holter recording at 6 months follow-up
measure: Persistent AF Arm
timeFrame: 24-hour Holter recording at 9 months follow-up.
Secondary outcomes:
measure: Permanent AF Arm
timeFrame: 24 hours
measure: Persistent AF Arm
timeFrame: 24-hour Holter recording at 9 months follow-up.
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Clinic - Department of Thoracic & Cardiovascular Surgery
state: Beneke Str. 2-8
city: Cottbus
country: Germany
facility: Heart Center Cottbus - Department of Cardiac Surgery
state: Leipziger Strasse 50
city: Trondheim
country: Norway
facility: St. Elizabeth Heart Center - Department of Cardiothoracic Surgery
state: Hans Nissens Gate 3
city: Bergen
country: Norway
facility: Haukeland University Hospital - Department of Cardiothoracic Surgery
state: Jonas Liesvei 65
city: Warsaw
country: Poland
facility: Public Central Teaching Hospital - Department of Cardiac Surgery
state: Ul. Banacha 1a
Study officials:
References: