AzTrials
AzTrials

Heart FailureAVATAR-AFNCT02459574

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

A study testing AVATAR-AF ablation, Anti-Arrhythmic therapy and Conventional AF ablation in people with Heart Failure and Recurrent Atrial Fibrillation, run by Imperial College London at 13 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Failure, Recurrent Atrial Fibrillation
What is being tested?
AVATAR-AF ablation, Anti-Arrhythmic therapy and Conventional AF ablation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
321 participants
Where
13 sitesUnited Kingdom
Study dates
1 May 2015to 27 Nov 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United Kingdom13 sites

  • The Royal Bournemouth Hospital

    Bournemouth, BH4 7DW

  • Brighton University Hospital

    Brighton, BN2 1ES

  • Coventry University Hospital

    Coventry, CV2 1EP

  • Eastbourne District General Hospital

    Eastbourne

  • Castle Hill Hospital

    Hull, HU16 5JQ

  • Leeds General Infirmary

    Leeds, LS1 3EX

  • Liverpool Heart and Chest Hospital

    Liverpool, L14 3PE

  • St Bartholomew's Hospital

    London, EC1A 7BE

  • Hammersmith Hospital

    London, W12 0NN

  • Freeman Hospital

    Newcastle, NE7 7DN

  • Queen Alexandra Hospital

    Portsmouth, PO6 3LY

  • Sheffield University Hospital

    Sheffield, S5 7AU

  • New Cross Hospital

    Wolverhampton

Other trials in United Kingdom

About this study

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.

Read the 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.

Being tested
AVATAR-AF ablation, Anti-Arrhythmic therapy, Conventional AF ablation
Keywords
Heart Failure
Medical subject headings
Heart Failure, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AVATAR-AF ablationProcedure or surgery

    Also called Ablation method-surgical

    Experimental ablation protocol

  • Anti-Arrhythmic therapyDrug

    Also called Amiodarone, Dronaderone, Sotalol, Beta blockers

    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 ablationProcedure or surgery

    Also called Ablation method-surgical

    Conventional ablation procedure

Study groups in NCT02459574
Study groupRoleWhat they receive
Group 3-Conventional AF AblationActive 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.
Receives: Procedure: Conventional AF ablation
Group 2-Anti-arrhythmic therapyActive 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.
Receives: Drug: Anti-Arrhythmic therapy
Group 1-AVATAR-AF Ablation ProtocolExperimentalAF 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.
Receives: Procedure: AVATAR-AF ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (3)

  1. Death or Stroke From Any Cause

    Composite outcome measure

    Measured: 12 months

  2. 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 - 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)

    Measured: 12 months

  3. All Hospital Episodes Which Result in a Change in Therapy for Atrial Arrhythmia

    Composite outcome measure - All hospital episodes which result in a change in therapy for atrial arrhythmia

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2015 (estimated)
  2. Study start1 May 2015
  3. Primary completion30 Sep 2018
  4. Study completion27 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02459574
Sponsor's protocol ID
AVATAR-AF
Acronym
AVATAR-AF
Status last verified
Oct 2024
First submitted
24 Apr 2015
Last updated
9 Oct 2024
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36576323

  • 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.

    PubMed 31152874

Questions about this trial

What is this clinical trial studying?

A study testing AVATAR-AF ablation, Anti-Arrhythmic therapy and Conventional AF ablation in people with Heart Failure and Recurrent Atrial Fibrillation, run by Imperial College London at 13 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All Hospital Episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02459574, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in