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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01863472
Other study ID # FF20/13 Version 03
Secondary ID
Status Completed
Phase N/A
First received May 19, 2013
Last updated November 18, 2016
Start date June 2013
Est. completion date November 2016

Study information

Verified date November 2016
Source Cardioangiologisches Centrum Bethanien
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date November 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
HeartLight(TM) Laser Balloon
With the HeartLight(TM) Laser Balloon pulmonary vein isolation is done endoscopically guided
irrigated radiofrequency current ablation
The irrigated radiofrequency current ablation is used for pulmonary vein isolation

Locations

Country Name City State
Czech Republic Na Homolce Hospital Prague
Germany Herz- und Gefäß-Klinik GmbH Bad Neustadt Bad Neustadt Bavaria
Germany Rheinische Friedrich-Wilhelms-Universität Bonn Bonn NRW
Germany Cardioangiologisches Centrum Bethanien Frankfurt/Main
Germany Städtisches Klinikum Karlsruhe, Medizinische Klinik IV Karlsruhe
Spain Hospital Universitari i Politecnic La Fe Valencia

Sponsors (1)

Lead Sponsor Collaborator
Boris Schmidt

Countries where clinical trial is conducted

Czech Republic,  Germany,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds between day 90 and 365 days after index procedure No
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