Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation
AVATAR-AF
1 other identifier
interventional
321
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started May 2015
Typical duration for not_applicable heart-failure
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2018
CompletedResults Posted
Study results publicly available
October 9, 2024
CompletedOctober 9, 2024
October 1, 2024
3.4 years
April 24, 2015
August 25, 2022
October 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All Hospital Episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia
Composite outcome measure - Hospital episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia
12 months
Secondary Outcomes (3)
Death or Stroke From Any Cause
12 months
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)
12 months
All Hospital Episodes Which Result in a Change in Therapy for Atrial Arrhythmia
12 months
Study Arms (3)
Group 3-Conventional AF Ablation
ACTIVE COMPARATORThis 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.
Group 2-Anti-arrhythmic therapy
ACTIVE COMPARATORAnti-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.
Group 1-AVATAR-AF Ablation Protocol
EXPERIMENTALAF 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.
Interventions
Experimental ablation protocol
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.
Conventional ablation procedure
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
The Royal Bournemouth Hospital
Bournemouth, BH4 7DW, United Kingdom
Brighton University Hospital
Brighton, BN2 1ES, United Kingdom
Coventry University Hospital
Coventry, CV2 1EP, United Kingdom
Eastbourne District General Hospital
Eastbourne, United Kingdom
Castle Hill Hospital
Hull, HU16 5JQ, United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE, United Kingdom
St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
Hammersmith Hospital
London, W12 0NN, United Kingdom
Freeman Hospital
Newcastle, NE7 7DN, United Kingdom
Queen Alexandra Hospital
Portsmouth, PO6 3LY, United Kingdom
Sheffield University Hospital
Sheffield, S5 7AU, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
Related Publications (2)
Kanagaratnam P, McCready J, Tayebjee M, Shepherd E, Sasikaran T, Todd D, Johnson N, Kyriacou A, Hayat S, Hobson NA, Mann I, Balasubramaniam R, Whinnett Z, Earley M, Petkar S, Veasey R, Kirubakaran S, Coyle C, Kim MY, Lim PB, O'Neill J, Davies DW, Peters NS, Babalis D, Linton N, Falaschetti E, Tanner M, Shah J, Poulter N. Ablation versus anti-arrhythmic therapy for reducing all hospital episodes from recurrent atrial fibrillation: a prospective, randomized, multi-centre, open label trial. Europace. 2023 Mar 30;25(3):863-872. doi: 10.1093/europace/euac253.
PMID: 36576323RESULTMann 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.
PMID: 31152874DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Prapa Kanagaratnam
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Prapa Kanagaratnam
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2015
First Posted
June 2, 2015
Study Start
May 1, 2015
Primary Completion
September 30, 2018
Study Completion
November 27, 2018
Last Updated
October 9, 2024
Results First Posted
October 9, 2024
Record last verified: 2024-10