N/A
N=321
Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation
Heart Failure · Recurrent Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02459574 ↗Enrolled (actual)
321
Serious AEs
12.8%
Results posted
Oct 2024
Primary outcome: Primary: All Hospital Episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia — 19; 76; 23 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AVATAR-AF ablation (Procedure); Anti-Arrhythmic therapy (Drug); Conventional AF ablation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All Hospital Episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia |
19; 76; 23 | <0.0001 sig |
| SECONDARY Death or Stroke From Any Cause |
0; 1; 0 | — |
| 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) |
3; 19; 7; 1; 18; 2 | — |
| SECONDARY All Hospital Episodes Which Result in a Change in Therapy for Atrial Arrhythmia |
— | — |
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.
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 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+] 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
Data sourced from ClinicalTrials.gov (NCT02459574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.