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

I

I-Med-Pro GmbH

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

360 participants in 2 patient groups

HeartLight® EGLA
Active Comparator group
Description:
Participants will be treated with the endoscopically guided laser ablation catheter
Treatment:
Device: Ablation catheter
Contact Force Sensing Irrigated RF ablation
Active Comparator group
Description:
Participants will be treated with a contact force sensing irrigated radiofrequency ablation catheter
Treatment:
Device: Ablation catheter

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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