Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation

Heart Failure Clinical Trial

— AVATAR-AF  

Official title:

Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459574
• Other study ID #: AVATAR-AF
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure
• Recurrent Atrial Fibrillation

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