heart rhythm disease irregular heart rhythm
Conditions
Interventions
Radio frequency ablation of the right and left atrium during open heart surgery
Sponsors
Medtronic
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1 Documented history of AF 2 Concomitant indication (other than AF) for open-heart surgery 3 Able to take the anticoagulant warfarin 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
Exclusion criteria: 1 NYHA functional class = IV, 2 Left ventricular ejection fraction 7.0 cm, 4 Need for emergent cardiac surgery (i.e. cardiogenic shock) or redo open heart surgery, 5 Previous atrial ablation, AV-nodal ablation, or surgical Maze procedure, 6 Pregnancy or desire to be pregnant within 12-months of the study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of AF after ablation | — |
Secondary
| Measure | Time frame |
|---|---|
| Use of antiarrhythmic medication and antithromboembolic mediaction after ablation. | — |
Countries
Netherlands
Outcome results
None listed