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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02459574
Other study ID # AVATAR-AF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2015
Est. completion date November 27, 2018

Study information

Verified date February 2019
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A streamlined AF ablation procedure done without PV mapping as a daycase is more effective than anti-arrhythmic drugs at reducing all hospital episodes for recurrent atrial fibrillation.


Description:

AVATAR-AF is a multicentre, randomised controlled study comparing a streamlined AVATAR-protocol ablation procedure to anti-arrhythmic therapy in patients with documented paroxysmal AF who are considered to be failing current strategy for AF. A secondary control arm will also compare the AVATAR-protocol to conventional AF ablation. 300 patients who are on no prior anti-arrhythmic, 'pill-in-pocket' or taking regular anti-arrhythmics will be randomised in a 1:1:1 manner to a treatment strategy of either AVATAR-protocol ablation, anti-arrhythmic therapy or conventional AF ablation and followed-up for 1 year.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date November 27, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Documented paroxysmal atrial fibrillation

2. Modification or initiation of anti-arrhythmic agent required for symptom control

3. Males or females eighteen (18) to eighty (80) years of age

4. Suitable candidate for catheter ablation

5. Signed informed consent

Exclusion Criteria:

1. Contraindication to catheter ablation

2. No carer to enable daycase discharge

3. Arrhythmias other than AF documented unless they have had curative ablation (eg. for atrial flutter)

4. No documentation of sinus rhythm within 3 months

5. Valvular or coronary heart disease needing regular follow up

6. EF <45% or moderate/severe LV dysfunction

7. Active gastrointestinal disease

8. Renal failure with creatinine >200 µmol/L or on dialysis

9. Active fever or infection

10. Life expectancy shorter than the trial

11. Allergy to contrast

12. Severe cerebrovascular disease

13. Bleeding or clotting disorders or inability to receive heparin

14. Uncontrolled diabetes (HbA1c =73 mmol/mol or HbA1c =64 mmol/mol and Fasting Blood Glucose =9.2 mmol/L)

15. Serum Potassium [K+] <3.5 mmol/L or >5.0 mmol/L

16. Malignancy needing surgery, chemotherapy or radiotherapy

17. Pregnancy or women of child-bearing potential not using a highly effective method of contraception

18. Must not have previous (4 weeks prior to screening) or current participation in another clinical trial with an investigational drug or investigational device

19. Unable to give informed consent

20. Uncontrolled thyroid disease defined as abnormal thyroid function tests causing cardiac manifestations within the last 6mths

21. Unable to attend follow up visits

Study Design


Intervention

Procedure:
AVATAR-AF ablation
Experimental ablation protocol
Drug:
Anti-Arrhythmic therapy
Group 2 will be prescribed medication listed below: Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone. You will then be discharged from clinic. A research nurse will contact you by phone to make sure there are no problems and can make hospital appointments if needed.
Procedure:
Conventional AF ablation
Conventional ablation procedure

Locations

Country Name City State
United Kingdom The Royal Bournemouth Hospital Bournemouth
United Kingdom Brighton University Hospital Brighton
United Kingdom Coventry University Hospital Coventry
United Kingdom Eastbourne District General Hospital Eastbourne
United Kingdom Castle Hill Hospital Hull
United Kingdom Leeds General Infirmary Leeds
United Kingdom Liverpool Heart and Chest Hospital Liverpool
United Kingdom Hammersmith Hospital London
United Kingdom St Bartholomew's Hospital London
United Kingdom Freeman Hospital Newcastle
United Kingdom Queen Alexandra Hospital Portsmouth
United Kingdom Sheffield University Hospital Sheffield
United Kingdom New Cross Hospital Wolverhampton

Sponsors (1)

Lead Sponsor Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary All hospital episodes (Emergency Room or patient request for OPD) related to treatment for atrial arrhythmia Composite outcome measure 12 months
Secondary Death or stroke from any cause Composite outcome measure 12 months
Secondary Any complications caused by the procedure (pericardial effusion, bleeding >2 units, phrenic nerve palsy and other) or the anti-arrhythmic drug (GI disturbance, skin irritation and other) Composite outcome measure 12 months
Secondary All hospital episodes which result in a change in therapy for atrial arrhythmia Composite outcome measure 12 months
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