Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Time to PVI |
Time from index procedure start until all (or all isolatable) pulmonary veins are electrically isolated at index procedure. Metric: Min. |
Data available immediately after index procedure |
|
Other |
Time to PVI + PWI |
Time from index procedure start until all (or all isolatable) pulmonary veins and posterior walls are electrically isolated at index procedure. Metric: Min. |
Data available immediately after index procedure |
|
Other |
Total procedure time |
Time from index procedure start until all catheters are removed from the veins. Metric: Min. |
Data available immediately after index procedure |
|
Other |
Ablation time PVI |
Cumulated time of radiofrequency (RF) energy delivery required to achieve PVI during index procedure. Metric: min. |
Data available immediately after index procedure |
|
Other |
Ablation time PVI + PWI |
Cumulated time of RF delivery required to achieve PVI + PWI during index procedure. Metric: min. |
Data available immediately after index procedure |
|
Other |
Fluoroscopy time PVI |
Cumulated X-ray delivery time from start procedure until PVI achieved during index procedure. Metric: min. |
Data available immediately after index procedure |
|
Other |
Fluoroscopy time PVI + PWI |
Cumulated X-ray delivery time from start procedure until all catheters removed from the veins in index procedure. Metric: min. |
Data available immediately after index procedure |
|
Other |
Fluoroscopy dose PVI |
Cumulated X-ray dose to the participant from start procedure until PVI achieved during index procedure. Metric: Gy x cm^2 |
Data available immediately after index procedure |
|
Other |
Fluoroscopy dose PVI + PWI |
Cumulated X-ray dose to the participant from start procedure until all catheters removed from the veins in index procedure. Metric: Gy x cm^2 |
Data available immediately after index procedure |
|
Other |
Index procedure vascular access complications |
The number of participants developing a complication related to vascular access in the right groin. Metric: n/N in % |
Data available one month after completion of the index procedure |
|
Other |
Index procedure tamponade/ effusions |
The number of participants developing symptoms and signs of pericardial effusion during or after the procedure. Metric: n/N in % |
Data available one day after completion of the index procedure |
|
Other |
Left atrial volume |
The left atrial volume before the index procedure and before the reassessment procedure after 6 months. Estimated with 1) Contrast-CT scan of left atrium, 2) Echo - measured left atrial volume and 3) Left atrial volume estimated by electroanatomical mapping (Carto ®, Biosense Webster.Inc). Metric: ml. |
Data available after completion of the reassessment procedure |
|
Other |
Left Ventricular Ejection Fraction (LVEF) |
The left ventricular systolic function estimated by LVEF before the index procedure, before the reassessment procedure after 6 months and at 1 year follow-up. Metric: % |
Data available 1 year after the index procedure |
|
Primary |
The safety of single procedure PVI + PWI |
Defined as the incidence of inflammation or other injury to the esophagus detected under mandated esophagoscopy on the day after PVI + PWI with radiofrequency ablation. The endoscopy is carried out, assessed and electronically stored by a board-certified gastroenterologist. Metric: n/N in %. |
Esophagoscopy is carried out at least 20 hours and less than 48 hours after the index ablation procedure |
|
Secondary |
Feasibility of a first-procedure PVI + PWI strategy |
Defined as the ability to achieve complete bidirectional isolation of the left atrial posterior wall as well as all pulmonary veins at a reasonable cost in terms of procedure-, ablation and fluoroscopy times and total patient radiation exposure. Electrical isolation is assessed by visual inspection of electrocardiograms and classical electrophysiological pacing- and sensing maneuvers in the left atrium. |
The data are available immediately after the end of the index PVI + PWI procedure |
|
Secondary |
Temperature in the esophagus during radiofrequency ablation |
Defined as the maximum temperature measured in degrees Celsius with one decimal and evaluated for each individual ablation during point-by-point ablations to achieve PVI + PWI. Metric: Degrees Celsius. |
The data are available immediately after the end of the index PVI + PWI procedure |
|
Secondary |
Durability of the PVI + PWI lesion set |
Defined as the proportions of pulmonary veins and left atrial posterior walls remaining durably isolated when controlled at the six months reassessment procedure. Electrical isolation is assessed by visual inspection of electrocardiograms and classical electrophysiological pacing- and sensing maneuvers in the left atrium. Metric: n/N in %. |
The data are available immediately after the end of the six months reassessment procedure |
|
Secondary |
AF recurrence short term |
Defined as the proportion of participants with recurring atrial fibrillation of at least 2 minutes duration and the time to the first recurrence detected during continuous rhythm monitoring by the implanted loop recorder in the time frame of 90 days from end blanking period to 180 days post index procedure (time of scheduled reassessment procedure). Metric: n/N in %. |
The data are available 180 days after the index procedure |
|
Secondary |
AF burden short term |
Defined as cumulated time in atrial fibrillation (minutes) divided by the total number of minutes in the 90 days observation period between end blanking period and time of scheduled reassessment procedure. Metric: min/min in %. |
The data are available 180 days after the index procedure |
|
Secondary |
AF recurrence long term |
Defined as the proportion of participants with recurring atrial fibrillation of at least 2 minutes duration and the time to the first recurrence detected during continuous rhythm monitoring by the implanted loop recorder in the time frame between the reassessment / reablation procedure at 180 days and full three years (1080 days) observation time after the index procedure. Metric n/N in %. |
The data are available 1080 days after the index procedure |
|
Secondary |
AF burden long term |
Defined as cumulated time in atrial fibrillation (minutes) divided by the total number of minutes in the 900 days observation period between the 6 months reassessment/ reablation procedure and full three years observation time (1080 days). Moreover, AF burden is calculated every 3 to 6 months during the entire follow - up period. Metric: min./min. in % |
The data are available 1080 days after the index procedure |
|
Secondary |
Long term efficacy PVI + PWI |
Defined as incidence of anti arrhythmic drug therapy and repeat ablations between the the reassessment procedure at 180 days and end follow-up at 1080 days. Metric: number of patients and specification of drug |
The data are available 1080 days after the index procedure |
|
Secondary |
Effect on quality of life by PVI + PWI |
Defined as self reported scores obtained by repeat answering of the Atrial Fibrillation Effect on Quality of Life (AFEQT) score system. The questionnaire is administered every three to six months to coincide with clinic visits and calculation of AF burden. Metric: range [0-100] |
Data are available from recruitment to end of follow-up at 3 years |
|