Trial Outcomes & Findings for Corticosteroid Pulse After Ablation (NCT NCT00807586)
NCT ID: NCT00807586
Last Updated: 2019-08-20
Results Overview
Clinically significant atrial arrhythmias include ER, urgent care, or hospitalization for atrial fibrillation, cardioversion for atrial fibrillation, or atrial fibrillation requiring an increase in anti-arrhythmia medication
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
119 participants
Primary outcome timeframe
6 weeks
Results posted on
2019-08-20
Participant Flow
Participant milestones
| Measure |
Steroid
Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure
|
Placebo
Placebo: Normal saline (1.6 cc)
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
59
|
|
Overall Study
COMPLETED
|
54
|
58
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Corticosteroid Pulse After Ablation
Baseline characteristics by cohort
| Measure |
Steroid
n=60 Participants
Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure
|
Placebo
n=59 Participants
Placebo: Normal saline (1.6 cc)
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 10.2 • n=99 Participants
|
60.0 years
STANDARD_DEVIATION 11.4 • n=107 Participants
|
60.1 years
STANDARD_DEVIATION 11.2 • n=206 Participants
|
|
Sex/Gender, Customized
Female
|
14 participants
n=99 Participants
|
13 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
46 participants
n=99 Participants
|
46 participants
n=107 Participants
|
92 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: 3 patients lost to follow-up
Clinically significant atrial arrhythmias include ER, urgent care, or hospitalization for atrial fibrillation, cardioversion for atrial fibrillation, or atrial fibrillation requiring an increase in anti-arrhythmia medication
Outcome measures
| Measure |
Steroid
n=58 Participants
Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure
|
Placebo
n=58 Participants
Placebo: Normal saline (1.6 cc)
|
|---|---|---|
|
Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks
|
4 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: one day and one weekPopulation: 4 patients lost to follow up
Perception of cardiac pain assessed by a numerical pain scale (0= no pain; 10=worst pain imaginable)
Outcome measures
| Measure |
Steroid
n=58 Participants
Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure
|
Placebo
n=57 Participants
Placebo: Normal saline (1.6 cc)
|
|---|---|---|
|
Cardiac Pain Assessment
Pain Scale Day 1
|
0.9 units on a scale
Standard Deviation 1.5
|
1.5 units on a scale
Standard Deviation 2.4
|
|
Cardiac Pain Assessment
Pain Scale Week 1
|
0.8 units on a scale
Standard Deviation 1.9
|
0.6 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Data were not collected on this outcome
Occurrence of shortness of breath or edema requiring administration of a diuretic
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: 14 patients lost to follow up
Need for repeat ablation
Outcome measures
| Measure |
Steroid
n=50 Participants
Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure
|
Placebo
n=55 Participants
Placebo: Normal saline (1.6 cc)
|
|---|---|---|
|
Repeat Intervention
|
2 Participants
|
8 Participants
|
Adverse Events
Steroid
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Steroid
n=60 participants at risk
Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure
|
Placebo
n=59 participants at risk
Placebo: Normal saline (1.6 cc)
|
|---|---|---|
|
Cardiac disorders
Atrial Flutter
|
8.3%
5/60 • Number of events 5 • there were Adverse Events collected from six weeks to 1 year
|
5.1%
3/59 • Number of events 3 • there were Adverse Events collected from six weeks to 1 year
|
|
Cardiac disorders
Chest Pain
|
1.7%
1/60 • Number of events 1 • there were Adverse Events collected from six weeks to 1 year
|
8.5%
5/59 • Number of events 5 • there were Adverse Events collected from six weeks to 1 year
|
|
Cardiac disorders
Shortness of Breath
|
11.7%
7/60 • Number of events 7 • there were Adverse Events collected from six weeks to 1 year
|
3.4%
2/59 • Number of events 2 • there were Adverse Events collected from six weeks to 1 year
|
|
Cardiac disorders
Fatigue
|
10.0%
6/60 • Number of events 6 • there were Adverse Events collected from six weeks to 1 year
|
1.7%
1/59 • Number of events 1 • there were Adverse Events collected from six weeks to 1 year
|
|
Cardiac disorders
Back Pain
|
5.0%
3/60 • Number of events 3 • there were Adverse Events collected from six weeks to 1 year
|
0.00%
0/59 • there were Adverse Events collected from six weeks to 1 year
|
|
Cardiac disorders
Edema/fluid overload
|
5.0%
3/60 • Number of events 3 • there were Adverse Events collected from six weeks to 1 year
|
1.7%
1/59 • Number of events 1 • there were Adverse Events collected from six weeks to 1 year
|
|
Cardiac disorders
Hypotension
|
0.00%
0/60 • there were Adverse Events collected from six weeks to 1 year
|
5.1%
3/59 • Number of events 3 • there were Adverse Events collected from six weeks to 1 year
|
|
Cardiac disorders
Abdominal Pain
|
0.00%
0/60 • there were Adverse Events collected from six weeks to 1 year
|
3.4%
2/59 • Number of events 2 • there were Adverse Events collected from six weeks to 1 year
|
Additional Information
Dr. Daniel Melby
Minneapolis Heart Institute Foundation
Phone: 612-863-3900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place