CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation (CF²)

I-Med-Pro

Status

Completed

Conditions

Paroxysmal Atrial Fibrillation

Treatments

Device: Ablation catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT03056222

CF2 Rev.1 IMP

Details and patient eligibility

About

The aim of the study is to compare the acute procedure and safety outcomes as well as long term clinical outcomes of 2 groups of patients treated with the HeartLight® Endoscopically Guided Laser Ablation (EGLA) or a commercially available Contact Force Sensing Irrigated Radiofrequency (RF) Ablation Catheter plus, at the operator's discretion, 3D Electroanatomical Mapping (EAM) for the treatment of Paroxysmal Atrial Fibrillation (PAF).

Enrollment

360 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient must not have undergone a previous ablation for the treatment of PAF
AF Type - Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) where PAF is defined as recurrent (two or more) episodes of AF that terminate spontaneously in less than seven days, usually less than 48 hours

Exclusion criteria

Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
Diagnosed with persistent atrial fibrillation defined as recurrent episodes lasting more than 7 and less than 365 days
More than 4 electrical cardioversions in the year prior to enrollment but not including cardioversions performed within 48 hours of arrhythmia onset
Documented left atrial thrombus on imaging
Cannot be removed from anti-arrhythmic drugs for other reasons than atrial fibrillation
New York Heart Association (NYHA) functional Class III or Class IV heart failure
Left ventricular ejection fraction < 30%
Left atrial size > 55 mm as measured in the parasternal antero-posterior view
Myocardial infarction within 60 days prior to enrolment
Woman of childbearing potential who is pregnant, lactating or not using adequate birth control