Clinical trial NCT03056222: CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation
Official title: CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: I-Med-Pro GmbH
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Freedom from symptomatic, recurrent atrial fibrillation (AF) off of anti-arrhythmic drugs
timeFrame: 12 months post procedure
Secondary outcomes:
measure: Acute procedure success
timeFrame: 30 minutes post procedure
measure: Procedure and fluoroscopy time
timeFrame: During procedure
measure: Incidence of peri-procedural complications
timeFrame: From procedure to 12 months post procedure
measure: Freedom from symptomatic, recurrent Atrial Tachy Arrhythmia (ATA) off of anti-arrhythmic drugs
timeFrame: 12 months post procedure
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Hartcentrum OLV Aalst
city: Hasselt
country: Belgium
facility: Hartcentrum Hasselt Jessa Ziekenhuis
city: Prague
country: Czechia
facility: Nemocnice Na Homolce
city: Erlangen
country: Germany
facility: Universitätsklinik Erlangen
state: Bavaria
city: München
country: Germany
facility: Isar Herz Zentrum
state: Bavaria
city: Köln
country: Germany
facility: St. Vinzenz Hospital Köln
state: NRW
city: Lübeck
country: Germany
facility: UKSH, Universitäres Herzzentrum
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum UKE Hamburg
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
Study officials:
affiliation: Universitäres Herz- und Gefäßzentrum UKE Hamburg
name: Andreas Metzner, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: