N/A
Completed N=200
Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation
Source: ClinicalTrials.gov NCT01014741 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Number of Participants With 1 Year Freedom From AF / AT — 65; 62; 27; 31 participants
Summary
Procedures for ablation of persistent or long lasting atrial fibrillation are frequently long and require extensive ablation. Some electrophysiologists administer the drug ibutilide during these procedures to help organize the fibrillatory activity of the left atrium with the hope that this may shorten the length of the procedure and duration of ablation needed. Currently there is no standardized approach of administering the drug ibutilide during these procedures, thus the investigators cannot be certain that administering this drug does in fact facilitate the procedure. The aim of the MAGIC-AF Trial is to see if administering a standard dose of the drug ibutilide at a standard time in the procedure can allow for a reduction in the ablation procedure time. The investigators hypothesize that administering ibutilide during these procedures will result in a reduction in the procedure and ablation time required.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 1 Year Freedom From AF / AT |
65; 62; 27; 31 | — |
| SECONDARY Procedure Time |
316; 321 | — |
| SECONDARY AF Termination |
66; 52; 39; 43 | — |
| SECONDARY Radiofrequency Ablation Time |
99; 104 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females will be enrolled in the study.
- Age >18
- Referred for a first ever ablation procedure for symptomatic persistent/permanent AF (only prior ablation of right-sided typical flutter is permitted)
- All patients must understand the requirements of the study and be willing to comply with the post study follow-up requirements.
- Patients must be in atrial fibrillation on the day of the procedure
Exclusion Criteria
- Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
- Patients with a myocardial infarction or unstable angina in the previous 2 months.
- Patients with a history of rheumatic heart disease
- Patients with congenital heart disease
- Patients with a history of hypertrophic cardiomyopathy
- Patients with LV ejection fraction 500msec)
- Prior left-sided cardiac ablation procedure (catheter based or surgical)
- Mental impairment precluding the patient from providing informed consent or completing the appropriate follow up
Data sourced from ClinicalTrials.gov (NCT01014741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.