NCT00826826

Brief Summary

The purpose of this study is to examine the overall effectiveness of short-time anti-arrhythmic drug treatment with amiodarone (to control heart rhythm) to prevent short-and long-term atrial fibrillation following an ablation procedure for atrial fibrillation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

2 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

January 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

5 years

First QC Date

January 20, 2009

Last Update Submit

March 4, 2014

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationAmiodaroneArrhythmias, CardiacCatheter ablation

Outcome Measures

Primary Outcomes (1)

  • Freedom from atrial fibrillation, atrial flutter or atrial tachycardia.

    Patients who (based upon clinical decision) are re-ablated within the blanking period counts as having reached an end point.

    6 months from ablation procedure

Secondary Outcomes (7)

  • Quality of Life

    6 months

  • Adverse outcome/intolerance of antiarrhythmic agent requiring cessation of drug

    6 months

  • Structural and electrical changes (evaluated by echocardiography and digital ECG).

    6 months

  • Atrial fibrillation burden evaluated by Holter monitoring

    6 months

  • Asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia documented with Holter.

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Amiodarone

ACTIVE COMPARATOR
Procedure: Catheter ablationDrug: Amiodarone

Placebo

PLACEBO COMPARATOR
Procedure: Catheter ablationDrug: Placebo

Interventions

Catheter ablationPROCEDURE

(Pulmonary vein isolation)

AmiodaronePlacebo
AmiodaroneDRUG

From the day of the catheter ablation procedure and 8 weeks forward.

Amiodarone
PlaceboDRUG

From the day of the catheter ablation procedure and 8 weeks forward.

Placebo

Eligibility Criteria

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

You may qualify if:

  • Patients with symptomatic paroxysmal or persistent atrial fibrillation undergoing catheter ablation for atrial fibrillation. (persistent episodes may last no more than 12 months)

You may not qualify if:

  • Contraindication or intolerance to amiodarone.
  • Prolonged amiodarone treatment within 3 months before the planned ablation procedure.
  • Previous participation in this study.
  • Other cardiac arrythmias (patients with co-existing atrial flutter can be included).
  • Antiarrhythmic treatment for indication other than atrial fibrillation (or atrial flutter).
  • Heart failure (NYHA class III or IV or left ventricular ejection fraction \< 35%).
  • Significant heart valve disease.
  • Significant lung disease, thyroid dysfunction or liver disease.
  • Inability or unwillingness to be treated with anticoagulation before and during the study.
  • Females with birth giving potential
  • Failure to give informed concent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Gentofte University Hospital

Hellerup, 2900, Denmark

Location

Related Publications (1)

  • Olsen FJ, Darkner S, Chen X, Pehrson S, Johannessen A, Hansen J, Svendsen JH, Biering-Sorensen T. Effect of Amiodarone after Catheter Ablation According to Left Atrial Structure and Function: The AMIO-CAT Trial. Am J Cardiol. 2026 Jan 15;259:63-70. doi: 10.1016/j.amjcard.2025.09.017. Epub 2025 Sep 24.

    PMID: 41005596DERIVED

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Interventions

Catheter AblationAmiodarone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Stine Darkner, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

  • Jesper H Svendsen, MD, DMSc

    Rigshospitalet, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 22, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

March 5, 2014

Record last verified: 2014-03

Locations

DK(2)