NCT03056222

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
4 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

April 10, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

4.4 years

First QC Date

February 14, 2017

Last Update Submit

November 18, 2021

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Acute procedure success

    30 minutes post procedure

  • Procedure and fluoroscopy time

    During procedure

  • Incidence of peri-procedural complications

    From procedure to 12 months post procedure

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

    12 months post procedure

Study Arms (2)

HeartLight® EGLA

ACTIVE COMPARATOR

Participants will be treated with the endoscopically guided laser ablation catheter

Device: Ablation catheter

Contact Force Sensing Irrigated RF ablation

ACTIVE COMPARATOR

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

Device: Ablation catheter

Interventions

Ablation catheterDEVICE

Ablation of paroxysmal atrial fibrillation

Contact Force Sensing Irrigated RF ablationHeartLight® EGLA

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hartcentrum OLV Aalst

Aalst, 9300, Belgium

Location

Hartcentrum Hasselt Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

Nemocnice Na Homolce

Prague, 15030, Czechia

Location

Universitätsklinik Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Isar Herz Zentrum

München, Bavaria, 80331, Germany

Location

St. Vinzenz Hospital Köln

Cologne, North Rhine-Westphalia, 50733, Germany

Location

UKSH, Universitäres Herzzentrum

Lübeck, Schleswig-Holstein, 23562, Germany

Location

Vivantes Klinikum Am Urban

Berlin, 10967, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

Universitäres Herz- und Gefäßzentrum UKE Hamburg

Hamburg, 20251, Germany

Location

Blackpool Victoria Hospital

Blackpool, FY3 8NR, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Andreas Metzner, PD Dr. med.

    Universitäres Herz- und Gefäßzentrum UKE Hamburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 17, 2017

Study Start

April 10, 2017

Primary Completion

August 16, 2021

Study Completion

November 15, 2021

Last Updated

November 19, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)BE(2)GB(1)DE(7)