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

Paroxysmal Atrial Fibrillation Clinical Trial

— CF²  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056222
• Other study ID #: CF2 Rev.1 IMP
• Status: Completed
• Phase: N/A
• Start date: April 10, 2017
• Est. completion date: November 15, 2021

Study information

• Verified date: November 2021
• Source: I-Med-Pro GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: November 15, 2021
• Est. primary completion date: August 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Ablation catheter
Ablation of paroxysmal atrial fibrillation

Locations

Country	Name	City	State
Belgium	Hartcentrum OLV Aalst	Aalst
Belgium	Hartcentrum Hasselt Jessa Ziekenhuis	Hasselt
Czechia	Nemocnice Na Homolce	Prague
Germany	Vivantes Klinikum Am Urban	Berlin
Germany	Universitätsklinik Erlangen	Erlangen	Bavaria
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Universitäres Herz- und Gefäßzentrum UKE Hamburg	Hamburg
Germany	St. Vinzenz Hospital Köln	Köln	NRW
Germany	UKSH, Universitäres Herzzentrum	Lübeck	Schleswig-Holstein
Germany	Isar Herz Zentrum	München	Bavaria
United Kingdom	Blackpool Victoria Hospital	Blackpool

Sponsors (1)

Lead Sponsor	Collaborator
I-Med-Pro GmbH

Countries where clinical trial is conducted

Belgium,  Czechia,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from symptomatic, recurrent atrial fibrillation (AF) off of anti-arrhythmic drugs	Recurrent AF is defined as any documented episode of AF lasting more than 30 seconds after a blanking period of 90 days post procedure	12 months post procedure
Secondary	Acute procedure success	Confirmation of electrical isolation with a circular mapping catheter	30 minutes post procedure
Secondary	Procedure and fluoroscopy time	Time will be taken	During procedure
Secondary	Incidence of peri-procedural complications	E.g. major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thrombo-embolic events, pulmonary vein (PV) -stenosis, atrial-to-esophageal fistula, death	From procedure to 12 months post procedure
Secondary	Freedom from symptomatic, recurrent Atrial Tachy Arrhythmia (ATA) off of anti-arrhythmic drugs	Recurrent ATA is defined as any documented episode of ATA lasting more than 30 seconds after a blanking period of 90 days post procedure	12 months post procedure