NCT02341105

Brief Summary

Randomized trial of low-dose amiodarone therapy versus catheter ablation (CA) in older patients with persistent atrial fibrillation (AF). Primary Objective: To compare amiodarone to catheter ablation in patients aged 50 to 80 years with symptomatic AF for the composite outcome of hospitalization for cardiovascular cause or emergency department visit for atrial arrhythmia

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_4 atrial-fibrillation

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

January 11, 2015

Last Update Submit

February 5, 2021

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • The composite outcome of hospitalization for cardiovascular cause or emergency department visit for atrial arrhythmia.

    2 years

Secondary Outcomes (3)

  • First recurrence of an atrial tachyarrhythmia documented on 12 lead ECG or a 14-day event monitor

    2 years

  • First recurrence of a symptomatic atrial tachyarrhythmia documented on 12 lead ECG or a 14-day event monitor

    2 years

  • Quality of life measured at 3, 6 and 12 months using the Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT)

    2 years

Other Outcomes (1)

  • Potential Side Effects Related to amiodarone or ablation procedure

    2 years

Study Arms (2)

Medical therapy

ACTIVE COMPARATOR

Amiodarone treatment. Amiodarone will be given at a loading dose of 400 mg per day for two week and then lowered to 200 mg daily for 6 months at which point the dose will be lowered to 1000 mg per week. The dose of amiodarone will then be lowered every six, as long as the patient has a satisfactory response. The minimum dose will be 700 mg per week.

Drug: Amiodarone

Catheter ablation

ACTIVE COMPARATOR

A standard pulmonary vein isolation procedure will be done. Additional ablation will be permitted (roof and mitral lines/ CFAE )

Procedure: Catheter ablation

Interventions

Catheter ablationPROCEDURE

Pulmonary vein isolation by catheter ablation

Also known as: Pulmonary Vein Isolation (PVI)
Catheter ablation
AmiodaroneDRUG

antiarrhythmic therapy using Amiodarone

Also known as: Antiarrhythmic
Medical therapy

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recurrent symptomatic Atrial Fibrillation (AF)
  • Age 50-80 years with persistent AF (≥1 of AF episode lasting more than a week or requiring cardioversion)

You may not qualify if:

  • Permanent atrial fibrillation
  • Prior continuous use of amiodarone of more than 2 weeks.
  • Prior catheter ablation for AF.
  • Have a documented resting heart (while awake) of \< 50 beats per minute.
  • Have a known severe liver disease.
  • Are deemed not suitable for CA (LA size, comorbidities…).
  • Have a severe valvular disease or have a mechanical mitral prosthesis.
  • Have a life-expectancy of less than 2 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter AblationAmiodaroneAnti-Arrhythmia Agents

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Guy Amit, MD

    Hamilton Heath Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2015

First Posted

January 19, 2015

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)