Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial

Conditions: Atrial fibrillation
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-002532-12-CZ

Lead Sponsor: Mayo Clinic

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 3000

Inclusion Criteria

1. Have documented AF episodes =1 hour in duration; with =2 episodes
over 4 months with electrocardiographic documentation of 1 episode or at least 1 episode of AF lasting more than 1 week
2. Warrant active therapy beyond simple ongoing observation.
3. Be eligible for catheter ablation and= 2 sequential rhytmn control and/or =3 rate control.
4. Be =65 years of age, or <65 years with one or more of the following risk factors of stroke: Hypertension defined as BP >140/90 mmHg Diabetes defined as a fasting glucose=126 mg/dl, Congestive heart failure (including systolic or diastolic heart failure), prior stroke or TIA, LA size >5.0 cm (or volume index = 40cc/m2), or EF =35. Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to quality.
5. Have the capacity to understand and sign an Informed concent form.
6. Be =18 years of age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
;
1. Have documented AF episodes =1 hour in duration; with =2 episodes
over 4 months with electrocardiographic documentation of 1 episode or at least 1 episode of AF lasting more than 1 week
2. Warrant active therapy beyond simple ongoing observation.
3. Be eligible for catheter ablation and= 2 sequential rhytmn control and/or =3 rate control.
4. Be =65 years of age, or <65 years with one or more of the following risk factors of stroke: Hypertension defined as BP >140/90 mmHg Diabetes defined as a fasting glucose=126 mg/dl, Congestive heart failure (including systolic or diastolic heart failure), prior stroke or TIA, LA size >5.0 cm (or volume index = 40cc/m2), or EF =35. Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to quality.
5. Have the capacity to understand and sign an Informed concent form.
6. Be =18 years of age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Lone AF in the absence of risk factors for stroke in patients <65 years of age
2. Patients who in the opinion of the managing clinician should not yet receive any therapy for AF
3. Patients who have failed =2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy or side effects
4. More than one week of amiodarone treatment in the past 3 months
5. An efficacy failure of full dose amiodarone treatment =12 weeks duration at any time
6. Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
7. Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months
8. Hypertrophic obstructive cardiomyopathy
9. Class IV angina or Class IV CHF (including past or planned heart transplantation) 10. Other mandated anti-arrhythmic drug therapy
11. Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs
12. Prior LA catheter ablation with the intention of treating AF
13. Prior surgical interventions for AF such as the MAZE procedure
14. Prior AV nodal ablation
15. Patients with other arrhythmias requiring ablative therapy
16. contraindication to warfarin anti-coagulation
17. Renal failure requiring dialys
18. Medical conditions limiting expected survival to <1 year
19. Women of childbearing potential (unless post-menopausal or surgically sterile)
20. Participation in any other clinical mortality trial
21. Unable to give informed consent
;
1. Lone AF in the absence of risk factors for stroke in patients <65 years of age
2. Patients who in the opinion of the managing clinician should not yet receive any therapy for AF
3. Patients who have failed =2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy or side effects
4. More than one week of amiodarone treatment in the past 3 months
5. An efficacy failure of full dose amiodarone treatment =12 weeks duration at any time
6. Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
7. Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months
8. Hypertrophic obstructive cardiomyopathy
9. Class IV angina or Class IV CHF (including past or planned heart transplantation) 10. Other mandated anti-arrhythmic drug therapy
11. Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs
12. Prior LA catheter ablation with the intention of treating AF
13. Prior surgical interventions for AF such as the MAZE procedure
14. Prior AV nodal ablation
15. Patients with other arrhythmias requiring ablative therapy
16. contraindication to warfarin anti-coagulation
17. Renal failure requiring dialys
18. Medical conditions limiting expected survival to <1 year
19. Women of childbearing potential (unless post-menopausal or surgically sterile)
20. Participation in any other clinical mortality trial
21. Unable to give informed consent