atrial fibrillation heart rhythm disorder
Conditions
Interventions
Treatment of atrial fibrillation using the Ablation Frontiers Cardiac Ablation
System.
Sponsors
Ablation Frontiers, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: History of symptomatic permanent atrial fibrillation lasting greater than seven days but less than four years with at least one failed DC cardioversion within the previous two years.
Exclusion criteria
Exclusion criteria: Structural heart disease of clinical significance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute - Use of AFI catheters to achieve procedure success. - Isolation of all accessible Pulmonary Veins - Elimination of CFAEs and high frequency intracardiac electrograms mapped and ablated with AFI catheters - Termination of AF upon leaving EP lab Chronic - Eighty percent reduction of sustained atrial fibrillation when evaluated for four consecutive days. - Off all rhythm control AADs at six months unless concomitant use for other cardiac disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Improvement of left atrial size compared to baseline. - Improvement of LV ejection fraction compared to baseline. - Improved Symptom Severity Score compared to baseline. - Improvement in the QoL. | — |
Countries
Netherlands
Outcome results
None listed