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CompletedNCT01863472Updated Nov 21, 2016

Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation

An interventional study of HeartLight(TM) Laser Balloon and irrigated radiofrequency current ablation in Persistent Atrial Fibrillation, sponsored by Boris Schmidt. Completed at 6 sites in 3 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-11-21.

Sponsored by Boris Schmidt · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the endoscopic ablation system in comparison to irrigated radiofrequency current ablation in patients with drug-refractory persistent atrial fibrillation.

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Conditions studied

  • Persistent Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 152 is close to the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

This is the only study on the registry with Boris Schmidt as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 to 80 years
  • persistent atrial fibrillation
  • failure of at least one antiarrhythmic drug
  • others

Exclusion criteria

Exclusion Criteria:

  • contraindications for pulmonary vein isolation (PVI)
  • previous PVI attempts
  • inability to be treated with oral anticoagulation
  • presence of intracardiac thrombi
  • pregnancy
  • others
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
152 participants (actual)

Study arms

  • Active comparator
    HeartLight(TM) Laser Balloon

    Safety and efficacy of pulmonary vein isolation using the HeartLight(TM) Laser Balloon (endoscopically guided ablation)

    Device: HeartLight(TM) Laser Balloon

  • Active comparator
    irrigated radiofrequency current ablation

    Safety and efficacy of pulmonary vein isolation using the irrigated radiofrequency current ablation

    Device: irrigated radiofrequency current ablation

Interventions

  • DeviceHeartLight(TM) Laser Balloon

    With the HeartLight(TM) Laser Balloon pulmonary vein isolation is done endoscopically guided

  • Deviceirrigated radiofrequency current ablation

    The irrigated radiofrequency current ablation is used for pulmonary vein isolation

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What researchers measure

Primary outcomes

  1. Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds

    Time frame: between day 90 and 365 days after index procedure

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Study locations

6 sites
  • Na Homolce Hospital
    Prague, 15030, Czech Republic
  • Herz- und Gefäß-Klinik GmbH Bad Neustadt
    Bad Neustadt, Bavaria 97616, Germany
  • Rheinische Friedrich-Wilhelms-Universität Bonn
    Bonn, NRW 53105, Germany
  • Cardioangiologisches Centrum Bethanien
    Frankfurt/Main, 60431, Germany
  • Städtisches Klinikum Karlsruhe, Medizinische Klinik IV
    Karlsruhe, 76133, Germany
  • Hospital Universitari i Politecnic La Fe
    Valencia, 46026, Spain
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References and documents

Publications

  • Schmidt B, Neuzil P, Luik A, Osca Asensi J, Schrickel JW, Deneke T, Bordignon S, Petru J, Merkel M, Sediva L, Klostermann A, Perrotta L, Cano O, Chun KRJ. Laser Balloon or Wide-Area Circumferential Irrigated Radiofrequency Ablation for Persistent Atrial Fibrillation: A Multicenter Prospective Randomized Study. Circ Arrhythm Electrophysiol. 2017 Dec;10(12):e005767. doi: 10.1161/CIRCEP.117.005767. PubMed 29217521 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01863472
Lead sponsor
Boris Schmidt
Responsible party
Boris Schmidt (Arzt für Kardiologie, Cardioangiologisches Centrum Bethanien) — Sponsor-investigator
First posted
May 29, 2013
Start date
Jun 2013
Primary completion
Sep 2016
Completion
Nov 2016
Last update
Nov 21, 2016

Study contacts

Boris Schmidt, Dr.
principal investigator · Cardioangiologisches Centrum Bethanien

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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