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Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation (AVATAR-AF)

Primary Purpose

Heart Failure, Recurrent Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
AVATAR-AF ablation
Anti-Arrhythmic therapy
Conventional AF ablation
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Royal Bournemouth Hospital
  • Brighton University Hospital
  • Coventry University Hospital
  • Eastbourne District General Hospital
  • Castle Hill Hospital
  • Leeds General Infirmary
  • Liverpool Heart and Chest Hospital
  • St Bartholomew's Hospital
  • Hammersmith Hospital
  • Freeman Hospital
  • Queen Alexandra Hospital
  • Sheffield University Hospital
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Group 3-Conventional AF Ablation

Group 2-Anti-arrhythmic therapy

Group 1-AVATAR-AF Ablation Protocol

Arm Description

This will involve an ablation procedure carried out in the usual manner. The patient will have three sheaths placed in the leg veins. Catheters will be passed up to the patient's heart from these veins. Two crossing are required into the left atrium. The ablation will involve freeze technology using the Advance Cryoballoon. It will include measuring the electrical signals and may also involve radiofrequency or 'burning' technology in addition.

Anti-arrhythmic drugs: On the treatment start date the patient will have a new tablet prescribed or a change in the dosage of the medication. The patient will be reviewed at 8wks (visit 1) later to see if the medication is working. If the tablets are working, the patients medication will be left unchanged. If not, an alternative tablet or a higher dose will be used.

AF ablation with pulmonary vein isolation. The patient will have two sheaths in their leg veins instead of the usual three sheaths. Catheters will be passed up to the heart from these leg veins. The single crossing into the left atrium will be by the usual method. Veins will be ablated using freeze technology known as the Advance Cryoballoon. After the ablation is completed the patient will have scans on their heart and checks of the leg veins. If all the checks are satisfactory at six hours after the procedure the patient will be allowed to go home on the same day. The patient will be reviewed in clinic in 8 weeks (visit 1) after the procedure and if it has been successful, will be reviewed again a month later (visit 2) and if all is well, the patient will be discharged from clinic.

Outcomes

Primary Outcome Measures

All hospital episodes (Emergency Room or patient request for OPD) related to treatment for atrial arrhythmia
Composite outcome measure

Secondary Outcome Measures

Death or stroke from any cause
Composite outcome measure
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
All hospital episodes which result in a change in therapy for atrial arrhythmia
Composite outcome measure

Full Information

First Posted
April 24, 2015
Last Updated
February 20, 2019
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT02459574
Brief Title
Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation
Acronym
AVATAR-AF
Official Title
Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
November 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Recurrent Atrial Fibrillation
Keywords
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 3-Conventional AF Ablation
Arm Type
Active Comparator
Arm Description
This will involve an ablation procedure carried out in the usual manner. The patient will have three sheaths placed in the leg veins. Catheters will be passed up to the patient's heart from these veins. Two crossing are required into the left atrium. The ablation will involve freeze technology using the Advance Cryoballoon. It will include measuring the electrical signals and may also involve radiofrequency or 'burning' technology in addition.
Arm Title
Group 2-Anti-arrhythmic therapy
Arm Type
Active Comparator
Arm Description
Anti-arrhythmic drugs: On the treatment start date the patient will have a new tablet prescribed or a change in the dosage of the medication. The patient will be reviewed at 8wks (visit 1) later to see if the medication is working. If the tablets are working, the patients medication will be left unchanged. If not, an alternative tablet or a higher dose will be used.
Arm Title
Group 1-AVATAR-AF Ablation Protocol
Arm Type
Experimental
Arm Description
AF ablation with pulmonary vein isolation. The patient will have two sheaths in their leg veins instead of the usual three sheaths. Catheters will be passed up to the heart from these leg veins. The single crossing into the left atrium will be by the usual method. Veins will be ablated using freeze technology known as the Advance Cryoballoon. After the ablation is completed the patient will have scans on their heart and checks of the leg veins. If all the checks are satisfactory at six hours after the procedure the patient will be allowed to go home on the same day. The patient will be reviewed in clinic in 8 weeks (visit 1) after the procedure and if it has been successful, will be reviewed again a month later (visit 2) and if all is well, the patient will be discharged from clinic.
Intervention Type
Procedure
Intervention Name(s)
AVATAR-AF ablation
Other Intervention Name(s)
Ablation method-surgical
Intervention Description
Experimental ablation protocol
Intervention Type
Drug
Intervention Name(s)
Anti-Arrhythmic therapy
Other Intervention Name(s)
Amiodarone, Dronaderone, Sotalol, Beta blockers, Calcium channel blockers, Flecainide, Propafenone
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional AF ablation
Other Intervention Name(s)
Ablation method-surgical
Intervention Description
Conventional ablation procedure
Primary Outcome Measure Information:
Title
All hospital episodes (Emergency Room or patient request for OPD) related to treatment for atrial arrhythmia
Description
Composite outcome measure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Death or stroke from any cause
Description
Composite outcome measure
Time Frame
12 months
Title
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)
Description
Composite outcome measure
Time Frame
12 months
Title
All hospital episodes which result in a change in therapy for atrial arrhythmia
Description
Composite outcome measure
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented paroxysmal atrial fibrillation Modification or initiation of anti-arrhythmic agent required for symptom control Males or females eighteen (18) to eighty (80) years of age Suitable candidate for catheter ablation Signed informed consent Exclusion Criteria: Contraindication to catheter ablation No carer to enable daycase discharge Arrhythmias other than AF documented unless they have had curative ablation (eg. for atrial flutter) No documentation of sinus rhythm within 3 months Valvular or coronary heart disease needing regular follow up EF <45% or moderate/severe LV dysfunction Active gastrointestinal disease Renal failure with creatinine >200 μmol/L or on dialysis Active fever or infection Life expectancy shorter than the trial Allergy to contrast Severe cerebrovascular disease Bleeding or clotting disorders or inability to receive heparin Uncontrolled diabetes (HbA1c ≥73 mmol/mol or HbA1c ≤64 mmol/mol and Fasting Blood Glucose ≥9.2 mmol/L) Serum Potassium [K+] <3.5 mmol/L or >5.0 mmol/L Malignancy needing surgery, chemotherapy or radiotherapy Pregnancy or women of child-bearing potential not using a highly effective method of contraception Must not have previous (4 weeks prior to screening) or current participation in another clinical trial with an investigational drug or investigational device Unable to give informed consent Uncontrolled thyroid disease defined as abnormal thyroid function tests causing cardiac manifestations within the last 6mths Unable to attend follow up visits
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Prapa Kanagaratnam
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH4 7DW
Country
United Kingdom
Facility Name
Brighton University Hospital
City
Brighton
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
Facility Name
Coventry University Hospital
City
Coventry
ZIP/Postal Code
CV2 1EP
Country
United Kingdom
Facility Name
Eastbourne District General Hospital
City
Eastbourne
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Liverpool Heart and Chest Hospital
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Queen Alexandra Hospital
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Sheffield University Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31152874
Citation
Mann I, Sasikaran T, Sandler B, Babalis D, Johnson N, Falaschetti E, Copley A, Tayebjee M, Todd D, Shepherd E, McCready J, Poulter N F, Kanagaratnam P. Ablation versus Anti-Arrhythmic Therapy for Reducing All Hospital Episodes from Recurrent Atrial Fibrillation (AVATAR-AF): Design and rationale. Am Heart J. 2019 Aug;214:36-45. doi: 10.1016/j.ahj.2019.04.015. Epub 2019 May 3.
Results Reference
derived

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

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