Trial Outcomes & Findings for RF Power, LSI and Oesophageal Temperature Alerts During AF Ablation (PiLOT-AF Study) (NCT NCT02619396)
NCT ID: NCT02619396
Last Updated: 2020-07-08
Results Overview
Number of patients with luminal oesophageal temperature rises \> 39◦C during radiofrequency (RF) ablation on the left atrial (LA) posterior wall
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
1 day
Results posted on
2020-07-08
Participant Flow
Participant milestones
| Measure |
Group "20 W / LSI 4"
Patients elected to AF ablation and randomized to Combination 1 of RF power and LSI on LA posterior wall
Combination 1 of RF power and LSI on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall
|
Group "40 W / LSI 4"
Patients elected to AF ablation and randomized to Combination 2 of RF power and LSI on LA posterior wall
Combination 2 of RF power and LSI on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall
|
Group "20 W / LSI 5"
Patients elected to AF ablation and randomized to Combination 3 of RF power and LSI on LA posterior wall
Combination 3 of RF power and LSI on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall
|
Group "40 W / LSI 5"
Patients elected to AF ablation and randomized to Combination 4 of RF power and LSI on LA posterior wall
Combination 4 of RF power and LSI on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group "20 W / LSI 4"
n=20 Participants
Patients elected to AF ablation and randomized to Combination 1 of RF power and Lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall
|
Group "40 W / LSI 4"
n=20 Participants
Patients elected to AF ablation and randomized to Combination 2 of RF power and Lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall
|
Group "20 W / LSI 5"
n=20 Participants
Patients elected to AF ablation and randomized to Combination 3 of RF power and Lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall
|
Group "40 W / LSI 5"
n=20 Participants
Patients elected to AF ablation and randomized to Combination 4 of RF power and Lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 9.2 • n=20 Participants
|
60.1 years
STANDARD_DEVIATION 9.4 • n=20 Participants
|
55.7 years
STANDARD_DEVIATION 10 • n=20 Participants
|
61.3 years
STANDARD_DEVIATION 9.6 • n=20 Participants
|
59.0 years
STANDARD_DEVIATION 9.6 • n=80 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
21 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
59 Participants
n=80 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
80 Participants
n=80 Participants
|
|
Paroxysmal atrial fibrillation (AF)
|
9 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
31 Participants
n=80 Participants
|
|
Atrial fibrillation (AF) history duration (months)
|
24 months
n=20 Participants
|
27 months
n=20 Participants
|
20 months
n=20 Participants
|
24 months
n=20 Participants
|
24 months
n=80 Participants
|
|
Body Mass Index (BMI)
|
30.8 BMI unit = kg/m^2
STANDARD_DEVIATION 4.6 • n=20 Participants
|
27.3 BMI unit = kg/m^2
STANDARD_DEVIATION 5 • n=20 Participants
|
28.2 BMI unit = kg/m^2
STANDARD_DEVIATION 4.85 • n=20 Participants
|
28.8 BMI unit = kg/m^2
STANDARD_DEVIATION 4.9 • n=20 Participants
|
29.2 BMI unit = kg/m^2
STANDARD_DEVIATION 6.3 • n=80 Participants
|
|
Left atrial (LA) size
|
43 diameter (mm)
STANDARD_DEVIATION 6 • n=20 Participants
|
41.4 diameter (mm)
STANDARD_DEVIATION 6.5 • n=20 Participants
|
42.4 diameter (mm)
STANDARD_DEVIATION 7.7 • n=20 Participants
|
43.7 diameter (mm)
STANDARD_DEVIATION 9.3 • n=20 Participants
|
42.8 diameter (mm)
STANDARD_DEVIATION 7.4 • n=80 Participants
|
|
Left ventricular (LV) function
|
60 LVEF (%)
STANDARD_DEVIATION 11.5 • n=20 Participants
|
60 LVEF (%)
STANDARD_DEVIATION 9.2 • n=20 Participants
|
60 LVEF (%)
STANDARD_DEVIATION 10.2 • n=20 Participants
|
57.9 LVEF (%)
STANDARD_DEVIATION 6.4 • n=20 Participants
|
59.4 LVEF (%)
STANDARD_DEVIATION 9.2 • n=80 Participants
|
PRIMARY outcome
Timeframe: 1 dayNumber of patients with luminal oesophageal temperature rises \> 39◦C during radiofrequency (RF) ablation on the left atrial (LA) posterior wall
Outcome measures
| Measure |
Group "20 W / LSI 4"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 1 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 1 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall
|
Group "40 W / LSI 4"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 2 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 2 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall
|
Group "20 W / LSI 5"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 3 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 3 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall
|
Group "40 W / LSI 5"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall
|
|---|---|---|---|---|
|
Rate of Oesophageal Temperature Alerts During Radiofrequency Energy (RF) Ablation on the Left Atrial (LA) Posterior Wall
|
18 Participants
|
18 Participants
|
19 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: 1 dayNumber of oesophageal temperature alerts per patient
Outcome measures
| Measure |
Group "20 W / LSI 4"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 1 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 1 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall
|
Group "40 W / LSI 4"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 2 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 2 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall
|
Group "20 W / LSI 5"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 3 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 3 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall
|
Group "40 W / LSI 5"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall
|
|---|---|---|---|---|
|
Oesophageal Temperature Alerts Per Patient
|
4 oesophageal temperature alerts
Interval 2.0 to 8.0
|
4 oesophageal temperature alerts
Interval 2.0 to 6.0
|
7 oesophageal temperature alerts
Interval 5.0 to 10.0
|
4 oesophageal temperature alerts
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: 1 dayPopulation: 80 pulmonary veins in each group (4 veins per patient, 20 patients)
Rate of Pulmonary Veins (PVs) isolated after completion of first Pulmonary Vein Encirclement
Outcome measures
| Measure |
Group "20 W / LSI 4"
n=80 number of pulmonary veins in each group
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 1 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 1 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall
|
Group "40 W / LSI 4"
n=80 number of pulmonary veins in each group
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 2 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 2 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall
|
Group "20 W / LSI 5"
n=80 number of pulmonary veins in each group
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 3 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 3 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall
|
Group "40 W / LSI 5"
n=80 number of pulmonary veins in each group
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall
|
|---|---|---|---|---|
|
Rate of First-pass Pulmonary Vein Isolation (PVI)
|
59 pulmonary veins
|
59 pulmonary veins
|
38 pulmonary veins
|
59 pulmonary veins
|
SECONDARY outcome
Timeframe: 1 dayPopulation: 80 pulmonary veins in each group (4 veins per patient, 20 patients)
Number of pulmonary veins acutely reconnected after catheter ablation and isolation
Outcome measures
| Measure |
Group "20 W / LSI 4"
n=80 number of pulmonary veins in each group
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 1 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 1 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall
|
Group "40 W / LSI 4"
n=80 number of pulmonary veins in each group
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 2 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 2 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall
|
Group "20 W / LSI 5"
n=80 number of pulmonary veins in each group
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 3 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 3 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall
|
Group "40 W / LSI 5"
n=80 number of pulmonary veins in each group
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall
|
|---|---|---|---|---|
|
Rate of Acute Pulmonary Vein Reconnection (PVR)
|
5 pulmonary veins
|
10 pulmonary veins
|
17 pulmonary veins
|
5 pulmonary veins
|
SECONDARY outcome
Timeframe: 1 dayTotal duration of the procedure
Outcome measures
| Measure |
Group "20 W / LSI 4"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 1 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 1 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall
|
Group "40 W / LSI 4"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 2 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 2 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall
|
Group "20 W / LSI 5"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 3 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 3 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall
|
Group "40 W / LSI 5"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall
|
|---|---|---|---|---|
|
Total Procedure Time
|
180 minutes
Interval 131.3 to 218.0
|
165 minutes
Interval 145.0 to 180.0
|
180 minutes
Interval 156.3 to 210.0
|
165 minutes
Interval 146.3 to 191.3
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Patients/ablation procedures per group
Total duration of radiofrequency energy required to achieve electrical isolation of the pulmonary veins
Outcome measures
| Measure |
Group "20 W / LSI 4"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 1 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 1 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall
|
Group "40 W / LSI 4"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 2 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 2 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall
|
Group "20 W / LSI 5"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 3 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 3 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall
|
Group "40 W / LSI 5"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall
|
|---|---|---|---|---|
|
Total Radiofrequency Energy (RF) Time for Pulmonary Vein Isolation (PVI)
|
28.4 minutes
Interval 25.2 to 40.1
|
23.8 minutes
Interval 16.9 to 34.7
|
38 minutes
Interval 28.4 to 46.3
|
22 minutes
Interval 18.7 to 33.8
|
SECONDARY outcome
Timeframe: 6 months after the procedurePopulation: Patients per group
Absence of symptoms suggestive of atrial fibrillation and no documentation of atrial fibrillation during the follow-up period
Outcome measures
| Measure |
Group "20 W / LSI 4"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 1 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 1 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall
|
Group "40 W / LSI 4"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 2 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 2 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall
|
Group "20 W / LSI 5"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 3 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 3 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall
|
Group "40 W / LSI 5"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall
|
|---|---|---|---|---|
|
Freedom From Atrial Fibrillation
|
8 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 months after the procedurePopulation: Patients per group
Difficult or painful swallowing, heartburn, acid reflux, sore throat, hoarseness, cough, nausea, vomiting, non-cardiac chest pain
Outcome measures
| Measure |
Group "20 W / LSI 4"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 1 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 1 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall
|
Group "40 W / LSI 4"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 2 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 2 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall
|
Group "20 W / LSI 5"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 3 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 3 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall
|
Group "40 W / LSI 5"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall
|
|---|---|---|---|---|
|
Esophageal Symptoms After the Atrial Fibrillation (AF) Ablation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 dayPericardial effusion, transient ischemic attack/stroke, phrenic nerve injury, pulmonary vein stenosis, open-heart surgery, death
Outcome measures
| Measure |
Group "20 W / LSI 4"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 1 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 1 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall
|
Group "40 W / LSI 4"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 2 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 2 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall
|
Group "20 W / LSI 5"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 3 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 3 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall
|
Group "40 W / LSI 5"
n=20 Participants
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall
|
|---|---|---|---|---|
|
Procedural Complications
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Group "20 W / LSI 4"
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group "40 W / LSI 4"
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Group "20 W / LSI 5"
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group "40 W / LSI 5"
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group "20 W / LSI 4"
n=20 participants at risk
Patients elected to AF ablation and randomized to Combination 1 of RF power and LSI on LA posterior wall
Combination 1 of RF power and LSI on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall
|
Group "40 W / LSI 4"
n=20 participants at risk
Patients elected to AF ablation and randomized to Combination 2 of RF power and LSI on LA posterior wall
Combination 2 of RF power and LSI on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall
|
Group "20 W / LSI 5"
n=20 participants at risk
Patients elected to AF ablation and randomized to Combination 3 of RF power and LSI on LA posterior wall
Combination 3 of RF power and LSI on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall
|
Group "40 W / LSI 5"
n=20 participants at risk
Patients elected to AF ablation and randomized to Combination 4 of RF power and LSI on LA posterior wall
Combination 4 of RF power and LSI on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall
|
|---|---|---|---|---|
|
Nervous system disorders
Stroke
|
0.00%
0/20 • 6 months
Regular investigator assessment before discharge after catheter ablation and at subsequent telephone follow-ups
|
5.0%
1/20 • Number of events 1 • 6 months
Regular investigator assessment before discharge after catheter ablation and at subsequent telephone follow-ups
|
0.00%
0/20 • 6 months
Regular investigator assessment before discharge after catheter ablation and at subsequent telephone follow-ups
|
0.00%
0/20 • 6 months
Regular investigator assessment before discharge after catheter ablation and at subsequent telephone follow-ups
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/20 • 6 months
Regular investigator assessment before discharge after catheter ablation and at subsequent telephone follow-ups
|
0.00%
0/20 • 6 months
Regular investigator assessment before discharge after catheter ablation and at subsequent telephone follow-ups
|
0.00%
0/20 • 6 months
Regular investigator assessment before discharge after catheter ablation and at subsequent telephone follow-ups
|
5.0%
1/20 • Number of events 1 • 6 months
Regular investigator assessment before discharge after catheter ablation and at subsequent telephone follow-ups
|
Other adverse events
Adverse event data not reported
Additional Information
Dr Milena Leo
John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust
Phone: 0186522055
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place