Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation
NCT ID: NCT02459574
Last Updated: 2024-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
321 participants
INTERVENTIONAL
2015-05-01
2018-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 3-Conventional AF Ablation
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.
Conventional AF ablation
Conventional ablation procedure
Group 2-Anti-arrhythmic therapy
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.
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.
Group 1-AVATAR-AF Ablation Protocol
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.
AVATAR-AF ablation
Experimental ablation protocol
Interventions
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AVATAR-AF ablation
Experimental ablation protocol
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.
Conventional AF ablation
Conventional ablation procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Dr. Prapa Kanagaratnam
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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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
St Bartholomew's Hospital
London, , United Kingdom
Hammersmith 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, , United Kingdom
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AVATAR-AF
Identifier Type: -
Identifier Source: org_study_id
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