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

• Status: Completed
• Trial end date: 2018-11-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Treatments: Adrenergic beta-Antagonists; Amiodarone; Anti-Arrhythmia Agents; Calcium Channel Blockers; Flecainide; Propafenone; Sotalol

Criteria

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