NCT01014741

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2009

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

May 24, 2017

Completed
Last Updated

February 14, 2018

Status Verified

January 1, 2018

Enrollment Period

5.3 years

First QC Date

November 16, 2009

Results QC Date

April 17, 2017

Last Update Submit

January 17, 2018

Conditions

Persistent Atrial Fibrillation

Keywords

Atrial FibrillationCatheter AblationComplex Fractionate Electrograms

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With 1 Year Freedom From AF / AT

    Freedom from atrial arrhythmia after repeat procedures with or without drugs

    one year

Secondary Outcomes (3)

  • Procedure Time

    at time of the procedure

  • AF Termination

    at time of the procedure

  • Radiofrequency Ablation Time

    at time of the procedure

Study Arms (2)

Ibutilide arm

EXPERIMENTAL
Drug: Ibutilide

Placebo arm

PLACEBO COMPARATOR
Drug: Placebo

Interventions

IbutilideDRUG

0.25mg IV ibutilide after PV isolation prior to CFE ablation

Ibutilide arm
PlaceboDRUG

Placebo after PV isolation prior to CFE ablation.

Placebo arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 \< 35%
  • Class IV congestive heart failure
  • Patients who have experienced any cerebral ischemic event, including any TIA in the preceding 1 month.
  • Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure.
  • Patients with any other significant uncontrolled or unstable medical condition (including uncontrolled clinically significant coagulation disorders).
  • Patients whose life expectancy is less than one year.
  • History of malignant ventricular arrhythmias or long QT interval (\>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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Regional Cardiology Associates

Sacramento, California, 95823, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University Of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Republic of Korea University Medical Center

Seoul, South Korea

Location

Related Publications (3)

  • Singh SM, d'Avila A, Kim YH, Aryana A, Mangrum JM, Michaud GF, Dukkipati SR, Barrett CD, Heist EK, Parides MK, Thorpe KE, Reddy VY. The modified stepwise ablation guided by low-dose ibutilide in chronic atrial fibrillation trial (The MAGIC-AF Study). Eur Heart J. 2016 May 21;37(20):1614-21. doi: 10.1093/eurheartj/ehw003. Epub 2016 Feb 4.

    PMID: 26850076RESULT

  • Singh SM, D'Avila A, Kim YH, Aryana A, Mangrum JM, Michaud GF, Dukkipati SR, Callans DJ, Barrett CD, Beras-Jovine MR, Reddy VY. The Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation (MAGIC-AF) Study: clinical background and study design. J Cardiovasc Electrophysiol. 2012 Apr;23(4):352-8. doi: 10.1111/j.1540-8167.2011.02198.x. Epub 2011 Oct 28.

    PMID: 22034996RESULT

  • Singh SM, d'Avila A, Kim YH, Aryana A, Mangrum JM, Michaud GF, Dukkipati SR, Barrett CD, Heist EK, Parides MK, Thorpe KE, Reddy VY. Termination of persistent atrial fibrillation during pulmonary vein isolation: insight from the MAGIC-AF trial. Europace. 2017 Oct 1;19(10):1657-1663. doi: 10.1093/europace/euw266.

    PMID: 27702847DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

ibutilide

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Vivek Reddy
Organization
Icahn School of Medicine at Mount Sinai
vivek.reddy@mountsinai.org
212-241-7114

Study Officials

  • Vivek Y Reddy, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director Cardiac Arrhythmia Service, Professor Of Medicine

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 17, 2009

Study Start

October 1, 2009

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 14, 2018

Results First Posted

May 24, 2017

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(5)KR(1)CA(1)