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

NCT ID: NCT03056222

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-10

Study Completion Date

2021-11-15

Brief Summary

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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).

Detailed Description

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Conditions

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Paroxysmal Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HeartLight® EGLA

Participants will be treated with the endoscopically guided laser ablation catheter

Group Type ACTIVE_COMPARATOR

Ablation catheter

Intervention Type DEVICE

Ablation of paroxysmal atrial fibrillation

Contact Force Sensing Irrigated RF ablation

Participants will be treated with a contact force sensing irrigated radiofrequency ablation catheter

Group Type ACTIVE_COMPARATOR

Ablation catheter

Intervention Type DEVICE

Ablation of paroxysmal atrial fibrillation

Interventions

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Ablation catheter

Ablation of paroxysmal atrial fibrillation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I-Med-Pro GmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Metzner, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universitäres Herz- und Gefäßzentrum UKE Hamburg

Locations

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Hartcentrum OLV Aalst

Aalst, , Belgium

Site Status

Hartcentrum Hasselt Jessa Ziekenhuis

Hasselt, , Belgium

Site Status

Nemocnice Na Homolce

Prague, , Czechia

Site Status

Universitätsklinik Erlangen

Erlangen, Bavaria, Germany

Site Status

Isar Herz Zentrum

München, Bavaria, Germany

Site Status

St. Vinzenz Hospital Köln

Cologne, North Rhine-Westphalia, Germany

Site Status

UKSH, Universitäres Herzzentrum

Lübeck, Schleswig-Holstein, Germany

Site Status

Vivantes Klinikum Am Urban

Berlin, , Germany

Site Status

Asklepios Klinik St. Georg

Hamburg, , Germany

Site Status

Universitäres Herz- und Gefäßzentrum UKE Hamburg

Hamburg, , Germany

Site Status

Blackpool Victoria Hospital

Blackpool, , United Kingdom

Site Status

Countries

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Belgium Czechia Germany United Kingdom

Other Identifiers

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CF2 Rev.1 IMP

Identifier Type: -

Identifier Source: org_study_id