Atrial Fibrillation Progression Trial

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 255

Inclusion Criteria

- Patients with recurrent AF for 2 years, with > or = to 6 episodes over the last 6 months;
- HATCH Score of at least > or = to 1 and < or = to 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 < or = 55mm by TTE.
- LV ejection fraction > or = to 50% when in sinus rhythm or LV ejection fraction > or = to 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.
- Previous cardioversion needed> 48 hours after the onset of AF / AT.
-Women of childbearing potential who are pregnant, breast-feeding or plan to become pregnant during the course of the trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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