Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial

Phase 1

Conditions: Atrial fibrillation
MedDRA version: 19.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-002532-12-DE

Lead Sponsor: Mayo Clinic

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2200

Inclusion Criteria

Over the preceding 6 months have:
a) >= 2 paroxysmal (electrocardiographic documentation of at least 1) AR episodes lasting >Z= 1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset); or
b) electrocardiographic documentation of 1 persistent AF episode (sustained for 7>= days or cardioversion is performed more than 48H after AF onset); or
c) electrocardiographic documentation of 1 longstanding persistent AF episode (continuos AF of duration > 1.
2.Warrant active therapy (within the past 3 months) beyond simple ongoing observation
3.Be eligible for catheter ablation and =2 sequential rhythm control and/or =2 rate control drugs.
4.Be =65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension (treated and/or defined as a BP >140/90 mmHg) [90], Diabetes (treated and/or defined as a fasting glucose =126 mg/dl) [91], Congestive heart failure (including systolic or diastolic heart failure), Prior stroke, TIA or systemic emboli, atherosclerotic vascular disease (previous MI, peripheral arterial disease or aortic plaque), LA size >5.0 cm (or volume index =40 cc/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 qualify.
5.Have the capacity to understand and sign an informed consent form.
6.Be =18 years of age.
NOTE: providing they remain realistically eligible for =2 membrane active drugs and/or =2 rate control agents. Patients receiving new drug therapy initiated within the previous 3 months may continue that therapy if randomized to the drug therapy arm.
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 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2000

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 (Table 5.2.2)
4. An efficacy failure of full dose amiodarone treatment >= 8weeks duration at any time
5. Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent
major surgical procedures, or trauma
6. Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3
NOTE:
months
7. Hypertrophic obstructive cardiomyopathy (outflow track)
8. Class IV angina or Class IV CHF (including past or planned heart transplantation)
9. Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. VT, VF)
10. Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs
11. Prior LA catheter ablation with the intention of treating AF
12. Prior surgical interventions for AF such as the MAZE procedure
13. Prior AV nodal ablation
14. Patients with other arrhythmias requiring ablative therapy
15. Contraindication to appropriate anti-coagulation therapy
16. Renal failure requiring dialysis
17. Medical conditions limiting expected survival to <1 year
18. Women of childbearing potential (unless post-menopausal or surgically sterile)
19. Participation in any other clinical mortality trial
20. Unable to give informed consent.
Note: Planned atrial flutter ablation in combination with the left atrial
ablation is not an exclusion. Exclusion Criterion #3 includes failed membrane active antiarrhythmic drugs started within 3 months prior to enrollment.