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

Atrial Fibrillation Clinical Trial

— AmioCAAF  

Official title:

AMIOCAAF (AMIOdarone vs. Catheter Ablation for Prevention of Recurrent Symptomatic Atrial Fibrillation): a Randomized Controlled Trial - Vanguard Phase

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02341105
• Other study ID #: AmioCaAF1
• Status: Terminated
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: February 2021
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Catheter ablation
Pulmonary vein isolation by catheter ablation

Drug:
• Amiodarone
antiarrhythmic therapy using Amiodarone

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Population Health Research Institute	Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Potential Side Effects Related to amiodarone or ablation procedure	Known potential side effects of catheter ablation include vascular access complications such as hematoma, pseudoaneurysm, or AV fistula. Less common but more serious include cardiac perforation (0.5%-1%) and thromboembolism (0.5%-1%), and fatal complications occur in approximately 1:1000 cases.; Known potential side effects of amiodarone include amiodarone toxicity, corneal micro-deposits, photosensitivity, thyroid abnormalities. pulmonary toxicity, abnormal liver function, and skin discolouration.	2 years
Primary	The composite outcome of hospitalization for cardiovascular cause or emergency department visit for atrial arrhythmia.		2 years
Secondary	First recurrence of an atrial tachyarrhythmia documented on 12 lead ECG or a 14-day event monitor		2 years
Secondary	First recurrence of a symptomatic atrial tachyarrhythmia documented on 12 lead ECG or a 14-day event monitor		2 years
Secondary	Quality of life measured at 3, 6 and 12 months using the Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT)		2 years