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OpenTrials
Completed

NCT Number: NCT03056222

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

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hartcentrum OLV Aalst, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ablation Catheter

Device

Ablation of paroxysmal atrial fibrillation

Primary outcomes

  1. Freedom from symptomatic, recurrent atrial fibrillation (AF) off of anti-arrhythmic drugs

    Time frame: 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 outcomes

  1. Acute procedure success

    Time frame: 30 minutes post procedure

    Confirmation of electrical isolation with a circular mapping catheter

  2. Procedure and fluoroscopy time

    Time frame: During procedure

    Time will be taken

  3. Incidence of peri-procedural complications

    Time frame: 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

  4. Freedom from symptomatic, recurrent Atrial Tachy Arrhythmia (ATA) off of anti-arrhythmic drugs

    Time frame: 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

Sponsors and collaborators

Lead sponsor

I-Med-Pro GmbH

Other

Registry information

Acronym: CF²

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2017
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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