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

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).

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: Ablation catheter

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Hartcentrum OLV Aalst
  • Hasselt, Belgium, 3500
    • Hartcentrum Hasselt Jessa Ziekenhuis
• Czechia
  • Prague, Czechia, 15030
    • Nemocnice Na Homolce
• Germany
  • Berlin, Germany, 10967
    • Vivantes Klinikum Am Urban
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg
  • Hamburg, Germany, 20251
    • Universitäres Herz- und Gefäßzentrum UKE Hamburg
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Universitätsklinik Erlangen
    • München, Bavaria, Germany, 80331
      • Isar Herz Zentrum
  • NRW
    • Köln, NRW, Germany, 50733
      • St. Vinzenz Hospital Köln
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23562
      • UKSH, Universitäres Herzzentrum
• United Kingdom
  • Blackpool, United Kingdom, FY3 8NR
    • Blackpool Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HeartLight® EGLA; Participants will be treated with the endoscopically guided laser ablation catheter	Device: Ablation catheter; Ablation of paroxysmal atrial fibrillation
Active Comparator: Contact Force Sensing Irrigated RF ablation; Participants will be treated with a contact force sensing irrigated radiofrequency ablation catheter	Device: Ablation catheter; Ablation of paroxysmal atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute procedure success	Confirmation of electrical isolation with a circular mapping catheter	30 minutes post procedure
Procedure and fluoroscopy time	Time will be taken	During procedure
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
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

Collaborators and Investigators

• Sponsor: I-Med-Pro GmbH
• Investigators: Principal Investigator: Andreas Metzner, PD Dr. med., Universitäres Herz- und Gefäßzentrum UKE Hamburg

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2017
• Primary Completion (Actual): August 16, 2021
• Study Completion (Actual): November 15, 2021

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CF2 Rev.1 IMP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes