EUCTR2011-002532-12-DE
Active, not recruiting
Phase 1
Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial - CABANA
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Atrial fibrillation
- Sponsor
- Mayo Clinic
- Enrollment
- 2200
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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
- •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
- •7\. Hypertrophic obstructive cardiomyopathy (outflow track)
- •8\. Class IV angina or Class IV CHF (including past or planned heart transplantation)
Outcomes
Primary Outcomes
Not specified
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