Atrial Fibrillation Progression Trial

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 330

Inclusion Criteria

1. Patients with recurrent paroxysmal AF for at least 2 years, with = 2 episodes over the last 6 months;
2. HATCH Score of at least =1 and = 4
3. 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).
4. Age 60 years or older.
5. Left Atrium diameter = 55mm by Trans Thoracic Echocardiographie.
6. Left Ventricule ejection fraction = 50% when in sinus rhythm or LV ejection fraction = 35% when in AF.
7. Patient signed the Informed Consent Form and is able and willing to comply with protocol requirements, including all baseline and follow- up 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

1.Patients awaiting cardiac transplantation or other cardiac surgery.
2.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.
3.Reversible causes of AF, e.g. but not limited to thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma,…
4.Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months.
5.Heart failure decompensation.
6.Previously diagnosed with persistent/permanent AF/AT
7.Previously required cardioversion >48 hours after onset of AF/AT
8.Subject having previous TIA or stroke (cerebrovascular accident) one year prior to patient enrolment and/or no
sufficient recovery.
9.Pulmonary embolism or recent atrial embolism/thrombosis.
10.Hypertrophic obstructive cardiomyopathy.
11.Class IV angina or Class IV CHF (including past or planned heart transplantation).
12.Mandated antiarrhythmic drug therapy for disease conditions other than AF.
13.Heritable arrhythmias or increased risk for torsade de pointes with class I or III Drugs.
14.Prior LA catheter ablation with the intention of treating AF; prior surgical interventions for AF such as the MAZE
procedure.
15.Prior AV nodal ablation.
16.Patients presenting contraindications
for the study catheter(s), as indicated in the respective Instructions For Use.
17.Contraindication to warfarin, other anticoagulation therapy, or all antiplatelet medications.
18.Medical conditions limiting expected survival to < 3 years.
19.Concurrent participation in any other clinical study.
20.Prior history of nonadherence
to prescribed drug regimens.
21.Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial