AMIOdarone vs. Catheter Ablation for Prevention of Recurrent Symptomatic Atrial Fibrillation

NCT ID: NCT02341105

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-01-31

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

Detailed Description

This is a single centre vanguard phase prospective randomized open label study with blinded outcome adjudication.

Patients will be randomized by a central randomization system (1:1) to amiodarone or catheter ablation.

1. Amiodarone will be started at a dose of 400 mg/day. After one month the dose will be lowered to 200 mg per day. Patients will be seen every six months. At each visit the dose of amiodarone will be lowered by 100 mg per week if the patient is having a good clinical response to treatment. Good clinical response will be a a clinical assessment that takes into account not only actual or possible arrhythmia recurrence but also side-effects and patient acceptability of treatment. A minimum dose of 700 mg/week will be allowed. If patient symptoms recur, the amiodarone dose may be increased but not above a dose of 200 mg/day .

2. Catheter ablation of persistent AF will be done within two months using pulmonary vein isolation in all subjects

3. Patient not in sinus rhythm at time randomization will undergo DC cardioversion after at least 1 month of amiodarone Rx or during CA.

Follow up: Clinical assessment will include a medical history and physical examination to be performed at baseline, and every 3 months. This will also include 12-lead ECG.

b. At 3, 6, 12, 18, and 24 months: QOL questionnaire (AFEQT- Atrial Fibrillation Effect on QualiTy of life) c. Thyroid and liver function tests, chest X-ray will be obtained at regular intervals.

d. Arrhythmia will be monitored using a 2-week event monitors at 6, 12, 18, 24 months.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medical therapy

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.

Group Type: ACTIVE_COMPARATOR

Amiodarone

Intervention Type: DRUG

antiarrhythmic therapy using Amiodarone

Catheter ablation

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

Group Type: ACTIVE_COMPARATOR

Catheter ablation

Intervention Type: PROCEDURE

Pulmonary vein isolation by catheter ablation

Interventions

Catheter ablation

Pulmonary vein isolation by catheter ablation

Intervention Type: PROCEDURE

Amiodarone

antiarrhythmic therapy using Amiodarone

Intervention Type: DRUG

Other Intervention Names

Pulmonary Vein Isolation (PVI); Antiarrhythmic

Eligibility Criteria

Inclusion Criteria

1. Recurrent symptomatic Atrial Fibrillation (AF)

2. Age 50-80 years with persistent AF (≥1 of AF episode lasting more than a week or requiring cardioversion)

Exclusion Criteria

1. Permanent atrial fibrillation

2. Prior continuous use of amiodarone of more than 2 weeks.

3. Prior catheter ablation for AF.

4. Have a documented resting heart (while awake) of < 50 beats per minute.

5. Have a known severe liver disease.

6. Are deemed not suitable for CA (LA size, comorbidities…).

7. Have a severe valvular disease or have a mechanical mitral prosthesis.

8. Have a life-expectancy of less than 2 years.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: collaborator

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guy Amit, MD

Role: PRINCIPAL_INVESTIGATOR

Hamilton Heath Sciences

Locations

Hamilton Health Sciences

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

AmioCaAF1

Identifier Type: -

Identifier Source: org_study_id