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=99 Participants
|
60 years
STANDARD_DEVIATION 9 • n=107 Participants
|
60 years
STANDARD_DEVIATION 10.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
156 Participants
n=206 Participants
|
|
Ejection Fraction
|
54 percent
STANDARD_DEVIATION 8 • n=99 Participants
|
55 percent
STANDARD_DEVIATION 8 • n=107 Participants
|
54.5 percent
STANDARD_DEVIATION 8 • n=206 Participants
|
|
Left atrial diameter
|
47 mm
STANDARD_DEVIATION 7 • n=99 Participants
|
46 mm
STANDARD_DEVIATION 8 • n=107 Participants
|
46.5 mm
STANDARD_DEVIATION 7.5 • n=206 Participants
|
|
Hypertension
yes
|
58 participants
n=99 Participants
|
58 participants
n=107 Participants
|
116 participants
n=206 Participants
|
|
Hypertension
no
|
47 participants
n=99 Participants
|
37 participants
n=107 Participants
|
84 participants
n=206 Participants
|
|
Diabetes
yes
|
15 participants
n=99 Participants
|
17 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Diabetes
no
|
90 participants
n=99 Participants
|
78 participants
n=107 Participants
|
168 participants
n=206 Participants
|
|
Coronary artery disease
yes
|
20 participants
n=99 Participants
|
10 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Coronary artery disease
no
|
85 participants
n=99 Participants
|
85 participants
n=107 Participants
|
170 participants
n=206 Participants
|
|
Stroke or transient ischaemic attack
yes
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Stroke or transient ischaemic attack
no
|
100 participants
n=99 Participants
|
89 participants
n=107 Participants
|
189 participants
n=206 Participants
|
|
Congestive heart failure
yes
|
16 participants
n=99 Participants
|
7 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Congestive heart failure
no
|
89 participants
n=99 Participants
|
88 participants
n=107 Participants
|
177 participants
n=206 Participants
|
|
CHA2DS2VASc score
|
1.6 units on a scale
STANDARD_DEVIATION 1.3 • n=99 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 1.3 • n=107 Participants
|
1.5 units on a scale
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
Duration of current AF episode
|
9 months
STANDARD_DEVIATION 21 • n=99 Participants
|
10 months
STANDARD_DEVIATION 22 • n=107 Participants
|
9.5 months
STANDARD_DEVIATION 21.5 • n=206 Participants
|
|
Duration of longest AF episode
|
11 month
STANDARD_DEVIATION 22 • n=99 Participants
|
12 month
STANDARD_DEVIATION 23 • n=107 Participants
|
11.5 month
STANDARD_DEVIATION 22.5 • n=206 Participants
|
|
Long-lasting AF
yes
|
16 participants
n=99 Participants
|
22 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Long-lasting AF
no
|
89 participants
n=99 Participants
|
73 participants
n=107 Participants
|
162 participants
n=206 Participants
|
|
Prior hospitalization for AF
yes
|
34 participants
n=99 Participants
|
32 participants
n=107 Participants
|
66 participants
n=206 Participants
|
|
Prior hospitalization for AF
no
|
71 participants
n=99 Participants
|
63 participants
n=107 Participants
|
134 participants
n=206 Participants
|
|
Prior cardioversion
yes
|
84 participants
n=99 Participants
|
71 participants
n=107 Participants
|
155 participants
n=206 Participants
|
|
Prior cardioversion
no
|
21 participants
n=99 Participants
|
24 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Statin use
yes
|
35 participants
n=99 Participants
|
37 participants
n=107 Participants
|
72 participants
n=206 Participants
|
|
Statin use
no
|
70 participants
n=99 Participants
|
58 participants
n=107 Participants
|
128 participants
n=206 Participants
|
|
ACE inhibitor/ARB use
yes
|
41 participants
n=99 Participants
|
39 participants
n=107 Participants
|
80 participants
n=206 Participants
|
|
ACE inhibitor/ARB use
no
|
64 participants
n=99 Participants
|
56 participants
n=107 Participants
|
120 participants
n=206 Participants
|
|
Current B-blocker use
yes
|
60 participants
n=99 Participants
|
50 participants
n=107 Participants
|
110 participants
n=206 Participants
|
|
Current B-blocker use
no
|
45 participants
n=99 Participants
|
45 participants
n=107 Participants
|
90 participants
n=206 Participants
|
|
Current anti-arrhythmic drug use
yes
|
39 participants
n=99 Participants
|
35 participants
n=107 Participants
|
74 participants
n=206 Participants
|
|
Current anti-arrhythmic drug use
no
|
66 participants
n=99 Participants
|
60 participants
n=107 Participants
|
126 participants
n=206 Participants
|
|
Prior anti-arrhythmic drug use
yes
|
37 participants
n=99 Participants
|
36 participants
n=107 Participants
|
73 participants
n=206 Participants
|
|
Prior anti-arrhythmic drug use
no
|
68 participants
n=99 Participants
|
59 participants
n=107 Participants
|
127 participants
n=206 Participants
|
|
Current amiodarone use
yes
|
6 participants
n=99 Participants
|
10 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Current amiodarone use
no
|
99 participants
n=99 Participants
|
85 participants
n=107 Participants
|
184 participants
n=206 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