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

NCT ID: NCT01863472

Last Updated: 2016-11-21

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

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Persistent 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(TM) Laser Balloon

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

Group Type ACTIVE_COMPARATOR

HeartLight(TM) Laser Balloon

Intervention Type DEVICE

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

irrigated radiofrequency current ablation

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

Group Type ACTIVE_COMPARATOR

irrigated radiofrequency current ablation

Intervention Type DEVICE

The irrigated radiofrequency current ablation is used for pulmonary vein isolation

Interventions

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HeartLight(TM) Laser Balloon

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

Intervention Type DEVICE

irrigated radiofrequency current ablation

The irrigated radiofrequency current ablation is used for pulmonary vein isolation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* contraindications for pulmonary vein isolation (PVI)
* previous PVI attempts
* inability to be treated with oral anticoagulation
* presence of intracardiac thrombi
* pregnancy
* others
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boris Schmidt

OTHER

Sponsor Role lead

Responsible Party

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Boris Schmidt

Arzt für Kardiologie

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Boris Schmidt, Dr.

Role: PRINCIPAL_INVESTIGATOR

Cardioangiologisches Centrum Bethanien

Locations

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Na Homolce Hospital

Prague, , Czechia

Site Status

Herz- und Gefäß-Klinik GmbH Bad Neustadt

Bad Neustadt an der Saale, Bavaria, Germany

Site Status

Rheinische Friedrich-Wilhelms-Universität Bonn

Bonn, North Rhine-Westphalia, Germany

Site Status

Cardioangiologisches Centrum Bethanien

Frankfurt am Main, , Germany

Site Status

Städtisches Klinikum Karlsruhe, Medizinische Klinik IV

Karlsruhe, , Germany

Site Status

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Site Status

Countries

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Czechia Germany Spain

References

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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.

Reference Type DERIVED
PMID: 29217521 (View on PubMed)

Other Identifiers

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FF20/13 Version 03

Identifier Type: -

Identifier Source: org_study_id