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

• ClinicalTrials.gov Identifier: NCT03056222
• Recruitment Status: Completed
• First Posted: February 17, 2017
• Last Update Posted: November 19, 2021
• Sponsor: I-Med-Pro GmbH
• Information provided by (Responsible Party): I-Med-Pro GmbH

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Paroxysmal Atrial Fibrillation	Device: Ablation catheter	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation
• Actual Study Start Date: April 10, 2017
• Actual Primary Completion Date: August 16, 2021
• Actual Study Completion Date: November 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

Belgium

Hartcentrum OLV Aalst

Aalst, Belgium, 9300

Hartcentrum Hasselt Jessa Ziekenhuis

Hasselt, Belgium, 3500

Czechia

Nemocnice Na Homolce

Prague, Czechia, 15030

Germany

Universitätsklinik Erlangen

Erlangen, Bavaria, Germany, 91054

Isar Herz Zentrum

München, Bavaria, Germany, 80331

St. Vinzenz Hospital Köln

Köln, NRW, Germany, 50733

UKSH, Universitäres Herzzentrum

Lübeck, Schleswig-Holstein, Germany, 23562

Vivantes Klinikum Am Urban

Berlin, Germany, 10967

Asklepios Klinik St. Georg

Hamburg, Germany, 20099

Universitäres Herz- und Gefäßzentrum UKE Hamburg

Hamburg, Germany, 20251

United Kingdom

Blackpool Victoria Hospital

Blackpool, United Kingdom, FY3 8NR

Sponsors and Collaborators

I-Med-Pro GmbH

Investigators

• Principal Investigator: Andreas Metzner, PD Dr. med.; Universitäres Herz- und Gefäßzentrum UKE Hamburg

More Information

• Responsible Party: I-Med-Pro GmbH
• ClinicalTrials.gov Identifier: NCT03056222
• Other Study ID Numbers: CF2 Rev.1 IMP
• First Posted: February 17, 2017
• Last Update Posted: November 19, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes