Atrial Fibrillation Progression Trial
Overview
- Phase
- Phase 4
- Intervention
- Catheter Ablation
- Conditions
- Atrial Fibrillation
- Sponsor
- Biosense Webster, Inc.
- Enrollment
- 255
- Primary Endpoint
- Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
The objective of this study is to determine whether early radiofrequency (RF) ablation treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with paroxysmal atrial fibrillation (PAF), delays progression of atrial fibrillation (AF) compared with drug therapy (either rate or rhythm control) using current AF management guidelines.
Detailed Description
Eligible PAF subjects with recurrent AF for 2 years who have failed no more than 2 prescribed drugs (with either anti-arrhythmic or rate control drug) are randomized into one of two study arms (catheter ablation or drug therapy).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with recurrent paroxysmal atrial fibrillation (AF) for at least 2 years, with ≥ 2 episodes over the last 6 months; (per Amendment v3, 09APR2013, previous "6 episodes" )
- •HATCH Score of at least ≥1 and ≤
- •Eligible for catheter ablation and for anti-arrhythmic or rate control medications, after having failed at least 1 but no more than 2 prescribed drugs (either anti-arrhythmic or rate control drug).
- •Age 60 years or older.
- •Left atrium (LA) diameter ≤ 55mm by TTE.
- •Left ventricle (LV) ejection fraction ≥50% when in sinus rhythm or LV ejection fraction ≥35% when in atrial fibrillation.
- •NOTE: For patients entering the study in AF with an ejection fraction ≥35% and \<50%; the ejection fraction should be re-checked when in sinus rhythm. In case the ejection fraction is \>50% the subject can continue in the study.
- •Patient signed the Informed Consent Form and is able and willing to comply with protocol requirements, including all baseline and follow-up testing.
Exclusion Criteria
- •Patients awaiting cardiac transplantation or other cardiac surgery.
- •Acute illness (ongoing) or active systemic infection or sepsis which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant of the study.
- •Reversible causes of atrial fibrillation, e.g. but not limited to thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma, etc.
- •Recent cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), or valve or bypass surgery in the preceding 3 months.
- •Heart failure decompensation.
- •Previously diagnosed with persistent/permanent atrial fibrillation/ atrial flutter.
- •Previously required cardioversion \>48 hours after onset of atrial fibrillation/ atrial flutter.
- •Subject having previous transischemic attack (TIA) or stroke (cerebrovascular accident) one year prior to patient enrolment and/or no sufficient recovery.
- •Pulmonary embolism or recent atrial embolism/thrombosis.
- •Hypertrophic obstructive cardiomyopathy.
Arms & Interventions
Catheter Ablation
Radiofrequency catheter ablation treatment in subjects with Paroxysmal Atrial Fibrillation (PAF)
Intervention: Catheter Ablation
Drug Treatment
Drug therapy (either rate or rhythm control) using current AF management guidelines
Intervention: Drug Treatment
Outcomes
Primary Outcomes
Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years
Time Frame: 3 years
Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Secondary Outcomes
- Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years(2 years)
- Number of Repeat Ablations(3 years)
- Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Year(3 year)
- Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year(1 year)
- Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year(1 year)
- Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up(3 months, 6 months, 1 year, 2 years, 3 years)
- Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up(3 months, 6 months, 1 year, 2 year and 3 years)
- Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years(2 Years)
- Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years by Number of Repeat Ablations(3 years)
- Number of New Antiarrhythmic Drugs(3 years)