European CURE-AF Study

NCT04645615 | Completed

• 1 other identifier: European CURE-AF Study
• Study Type: interventional
• Target: 26
• Locations: 3 countries
• Sites: 5

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Permanent AF Arm

  24 hours

• Persistent AF Arm

  24-hour Holter recording at 9 months follow-up.

Study Arms (1)

CURE AF

EXPERIMENTAL

Device: Cardioblate surgical ablation system; Procedure: Surgical RF Ablation

Interventions

Cardioblate surgical ablation system DEVICE

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.

CURE AF

Surgical RF Ablation PROCEDURE

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.

CURE AF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (5)

Kerckhoff Clinic - Department of Thoracic & Cardiovascular Surgery

Bad Nauheim, Beneke Str. 2-8, 61231, Germany

Location

Heart Center Cottbus - Department of Cardiac Surgery

Cottbus, Leipziger Strasse 50, 03048, Germany

Location

St. Elizabeth Heart Center - Department of Cardiothoracic Surgery

Trondheim, Hans Nissens Gate 3, 7018, Norway

Location

Haukeland University Hospital - Department of Cardiothoracic Surgery

Bergen, Jonas Liesvei 65, 5021, Norway

Location

Public Central Teaching Hospital - Department of Cardiac Surgery

Warsaw, Ul. Banacha 1a, 02-097, Poland

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 27, 2020
• Study Start: June 19, 2008
• Primary Completion: February 1, 2011
• Study Completion: July 10, 2013
• Last Updated: November 27, 2020

Record last verified: 2020-11

Locations

PL (1); NO (2); DE (2)