Trial Outcomes & Findings for Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation (NCT NCT01014741)
NCT ID: NCT01014741
Last Updated: 2018-02-14
Results Overview
Freedom from atrial arrhythmia after repeat procedures with or without drugs
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
one year
Results posted on
2018-02-14
Participant Flow
Participant milestones
| Measure |
Ibutilide Arm
Ibutilide: 0.25mg IV ibutilide after pulmonary vein isolation (PVI) isolation prior to complex fractionated atrial electrograms (CFAE) ablation
|
Placebo Arm
Placebo: Placebo after PVI isolation prior to CFAE ablation.
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
95
|
|
Overall Study
COMPLETED
|
94
|
90
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Ibutilide Arm
n=105 Participants
Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
|
Placebo Arm
n=95 Participants
Placebo: Placebo after PVI isolation prior to CFAE ablation.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 12 • n=93 Participants
|
60 years
STANDARD_DEVIATION 9 • n=4 Participants
|
60 years
STANDARD_DEVIATION 10.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
156 Participants
n=27 Participants
|
|
Ejection Fraction
|
54 percent
STANDARD_DEVIATION 8 • n=93 Participants
|
55 percent
STANDARD_DEVIATION 8 • n=4 Participants
|
54.5 percent
STANDARD_DEVIATION 8 • n=27 Participants
|
|
Left atrial diameter
|
47 mm
STANDARD_DEVIATION 7 • n=93 Participants
|
46 mm
STANDARD_DEVIATION 8 • n=4 Participants
|
46.5 mm
STANDARD_DEVIATION 7.5 • n=27 Participants
|
|
Hypertension
yes
|
58 participants
n=93 Participants
|
58 participants
n=4 Participants
|
116 participants
n=27 Participants
|
|
Hypertension
no
|
47 participants
n=93 Participants
|
37 participants
n=4 Participants
|
84 participants
n=27 Participants
|
|
Diabetes
yes
|
15 participants
n=93 Participants
|
17 participants
n=4 Participants
|
32 participants
n=27 Participants
|
|
Diabetes
no
|
90 participants
n=93 Participants
|
78 participants
n=4 Participants
|
168 participants
n=27 Participants
|
|
Coronary artery disease
yes
|
20 participants
n=93 Participants
|
10 participants
n=4 Participants
|
30 participants
n=27 Participants
|
|
Coronary artery disease
no
|
85 participants
n=93 Participants
|
85 participants
n=4 Participants
|
170 participants
n=27 Participants
|
|
Stroke or transient ischaemic attack
yes
|
5 participants
n=93 Participants
|
6 participants
n=4 Participants
|
11 participants
n=27 Participants
|
|
Stroke or transient ischaemic attack
no
|
100 participants
n=93 Participants
|
89 participants
n=4 Participants
|
189 participants
n=27 Participants
|
|
Congestive heart failure
yes
|
16 participants
n=93 Participants
|
7 participants
n=4 Participants
|
23 participants
n=27 Participants
|
|
Congestive heart failure
no
|
89 participants
n=93 Participants
|
88 participants
n=4 Participants
|
177 participants
n=27 Participants
|
|
CHA2DS2VASc score
|
1.6 units on a scale
STANDARD_DEVIATION 1.3 • n=93 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 1.3 • n=4 Participants
|
1.5 units on a scale
STANDARD_DEVIATION 1.3 • n=27 Participants
|
|
Duration of current AF episode
|
9 months
STANDARD_DEVIATION 21 • n=93 Participants
|
10 months
STANDARD_DEVIATION 22 • n=4 Participants
|
9.5 months
STANDARD_DEVIATION 21.5 • n=27 Participants
|
|
Duration of longest AF episode
|
11 month
STANDARD_DEVIATION 22 • n=93 Participants
|
12 month
STANDARD_DEVIATION 23 • n=4 Participants
|
11.5 month
STANDARD_DEVIATION 22.5 • n=27 Participants
|
|
Long-lasting AF
yes
|
16 participants
n=93 Participants
|
22 participants
n=4 Participants
|
38 participants
n=27 Participants
|
|
Long-lasting AF
no
|
89 participants
n=93 Participants
|
73 participants
n=4 Participants
|
162 participants
n=27 Participants
|
|
Prior hospitalization for AF
yes
|
34 participants
n=93 Participants
|
32 participants
n=4 Participants
|
66 participants
n=27 Participants
|
|
Prior hospitalization for AF
no
|
71 participants
n=93 Participants
|
63 participants
n=4 Participants
|
134 participants
n=27 Participants
|
|
Prior cardioversion
yes
|
84 participants
n=93 Participants
|
71 participants
n=4 Participants
|
155 participants
n=27 Participants
|
|
Prior cardioversion
no
|
21 participants
n=93 Participants
|
24 participants
n=4 Participants
|
45 participants
n=27 Participants
|
|
Statin use
yes
|
35 participants
n=93 Participants
|
37 participants
n=4 Participants
|
72 participants
n=27 Participants
|
|
Statin use
no
|
70 participants
n=93 Participants
|
58 participants
n=4 Participants
|
128 participants
n=27 Participants
|
|
ACE inhibitor/ARB use
yes
|
41 participants
n=93 Participants
|
39 participants
n=4 Participants
|
80 participants
n=27 Participants
|
|
ACE inhibitor/ARB use
no
|
64 participants
n=93 Participants
|
56 participants
n=4 Participants
|
120 participants
n=27 Participants
|
|
Current B-blocker use
yes
|
60 participants
n=93 Participants
|
50 participants
n=4 Participants
|
110 participants
n=27 Participants
|
|
Current B-blocker use
no
|
45 participants
n=93 Participants
|
45 participants
n=4 Participants
|
90 participants
n=27 Participants
|
|
Current anti-arrhythmic drug use
yes
|
39 participants
n=93 Participants
|
35 participants
n=4 Participants
|
74 participants
n=27 Participants
|
|
Current anti-arrhythmic drug use
no
|
66 participants
n=93 Participants
|
60 participants
n=4 Participants
|
126 participants
n=27 Participants
|
|
Prior anti-arrhythmic drug use
yes
|
37 participants
n=93 Participants
|
36 participants
n=4 Participants
|
73 participants
n=27 Participants
|
|
Prior anti-arrhythmic drug use
no
|
68 participants
n=93 Participants
|
59 participants
n=4 Participants
|
127 participants
n=27 Participants
|
|
Current amiodarone use
yes
|
6 participants
n=93 Participants
|
10 participants
n=4 Participants
|
16 participants
n=27 Participants
|
|
Current amiodarone use
no
|
99 participants
n=93 Participants
|
85 participants
n=4 Participants
|
184 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: one yearPopulation: Ninety-two patients in the ibutilide group and 93 patients in the placebo group remained in AF after study drug administration and underwent CFAE ablation.
Freedom from atrial arrhythmia after repeat procedures with or without drugs
Outcome measures
| Measure |
Ibutilide Arm
n=92 Participants
Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
|
Placebo Arm
n=93 Participants
Placebo: Placebo after PVI isolation prior to CFAE ablation.
|
|---|---|---|
|
Number of Participants With 1 Year Freedom From AF / AT
yes
|
65 participants
|
62 participants
|
|
Number of Participants With 1 Year Freedom From AF / AT
no
|
27 participants
|
31 participants
|
SECONDARY outcome
Timeframe: at time of the procedureOverall procedure duration
Outcome measures
| Measure |
Ibutilide Arm
n=105 Participants
Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
|
Placebo Arm
n=95 Participants
Placebo: Placebo after PVI isolation prior to CFAE ablation.
|
|---|---|---|
|
Procedure Time
|
316 minutes
Standard Deviation 79
|
321 minutes
Standard Deviation 81
|
SECONDARY outcome
Timeframe: at time of the procedureAF termination with complex fractionated atrial electrograms (CFAE) ablation
Outcome measures
| Measure |
Ibutilide Arm
n=105 Participants
Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
|
Placebo Arm
n=95 Participants
Placebo: Placebo after PVI isolation prior to CFAE ablation.
|
|---|---|---|
|
AF Termination
yes
|
66 participants
|
52 participants
|
|
AF Termination
no
|
39 participants
|
43 participants
|
SECONDARY outcome
Timeframe: at time of the procedureOutcome measures
| Measure |
Ibutilide Arm
n=105 Participants
Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
|
Placebo Arm
n=95 Participants
Placebo: Placebo after PVI isolation prior to CFAE ablation.
|
|---|---|---|
|
Radiofrequency Ablation Time
|
99 minutes
Standard Deviation 37
|
104 minutes
Standard Deviation 42
|
Adverse Events
Ibutilide Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Vivek Reddy
Icahn School of Medicine at Mount Sinai
Phone: 212-241-7114
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place