Paroxysmal Atrial Fibrillation
Conditions
Brief summary
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).
Interventions
DEVICEAblation catheter
Ablation of paroxysmal atrial fibrillation
Sponsors
I-Med-Pro GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from symptomatic, recurrent atrial fibrillation (AF) off of anti-arrhythmic drugs | 12 months post procedure | Recurrent AF is defined as any documented episode of AF lasting more than 30 seconds after a blanking period of 90 days post procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute procedure success | 30 minutes post procedure | Confirmation of electrical isolation with a circular mapping catheter |
| Procedure and fluoroscopy time | During procedure | Time will be taken |
| Incidence of peri-procedural complications | From procedure to 12 months post procedure | E.g. major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thrombo-embolic events, pulmonary vein (PV) -stenosis, atrial-to-esophageal fistula, death |
| Freedom from symptomatic, recurrent Atrial Tachy Arrhythmia (ATA) off of anti-arrhythmic drugs | 12 months post procedure | Recurrent ATA is defined as any documented episode of ATA lasting more than 30 seconds after a blanking period of 90 days post procedure |
Countries
Belgium, Czechia, Germany, United Kingdom
Outcome results
None listed