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NCT00958165 Clinical Trial

Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CFEAS- AC) for the Treatment of Symptomatic Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CFEAS- AC) for the Treatment of Symptomatic Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00958165
Other study ID # 25-2738
Secondary ID
Status Completed
Phase Phase 3
First received August 12, 2009
Last updated June 19, 2012
Start date August 2009
Est. completion date May 2012

Study information
Verified date June 2012
Source CardioFocus
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and effectiveness of the endoscopic ablation system - adaptive contact (EAS-AC) in treated paroxysmal atrial fibrillation (PAF) with pulmonary vein isolation (PVI).

Recruitment information / eligibility
Status Completed
Enrollment 81
Est. completion date May 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Symptomatic, Paroxysmal atrial fibrillation (AF)

- 18 to 70 years of age

- Failure of at least one AAD

- Others

Exclusion Criteria:

- Generally good overall health as determined by multiple criteria

- Willing to participate in a study

- Others

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• CardioFocus EAS-AC
PVI for PAF

Locations
Country Name City State
Germany Cardioangiologisches Centrum Bethanien - CCB Frankfurg
Germany St. Georg Hosptial Hamburg
Germany Universität Leipzig - Herzzentrum Leipzig

Sponsors (1)
Lead Sponsor Collaborator
CardioFocus

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Chronic effectiveness in treating PAF. 1 year No
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