Atrial Fibrillation Progression Trial

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 255

Inclusion Criteria

• Patients with recurrent AF for 2 years, with = 2 episodes over the last 6 months; 1 episode within the last 1 year (12 months) must be documented by electrocardiogram (ECG), TTM, HM, or telemetry strip.
• HATCH Score of at least =1 and = 4.
• Eligible for catheter ablation and for anti-arrhythmic or rate control medications, after having failed no more than 2 prescribed drugs (either anti-arrhythmic or rate control drug).
• Age 60 years or older.
• LA diameter = 55mm by TTE.
• LV ejection fraction = 50% when in sinus rhythm or LV ejection fraction = 35% when in AF.
• Signed Patient Informed Consent Form.
• Able and willing to comply with protocol requirements, including all baseline and followup testing
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 280

Exclusion Criteria

• Patients awaiting cardiac transplantation or other cardiac surgery.
• Acute illness (ongoing) or active systemic infection or sepsis.
• Reversible causes of AF, including thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma.
• Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months.
• Heart failure decompensation.
• Previous stroke.
• Pulmonary embolism or recent atrial embolism/thrombosis.
• Hypertrophic obstructive cardiomyopathy.
• Class IV angina or Class IV CHF (including past or planned heart transplantation).
• Mandated anti-arrhythmic drug therapy for disease conditions other than AF.
• Heritable arrhythmias or increased risk for torsade de pointes with class I or III Drugs.
• Prior LA catheter ablation with the intention of treating AF; prior surgical interventions for AF such as the MAZE procedure.
• Prior AV nodal ablation.
• Patients presenting contra-indications for the study catheter(s), as indicated in the respective Instructions For Use.
• Contraindication to warfarin, other anticoagulation therapy, or all anti-platelet medications.
• Medical conditions limiting expected survival to < 3 years.
• Concurrent participation in any other clinical study.
• Prior history of non-adherence to prescribed drug regimens.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to determine whether early 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 AF (PAF), delays progression of AF compared with drug therapy (either rate or rhythm control) using current AF management guidelines.;Secondary Objective: Not applicable;Primary end point(s): Time to persistent AF/AT (excluding isthmus-dependent atrial flutter) at 3 years. Persistent AF/AT is defined as AF/AT lasting longer than 7 consecutive days or requiring termination<br>by cardioversion after 48 hours.;Timepoint(s) of evaluation of this end point: 3 years

Secondary Outcome Measures

Name	Time	Method

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