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Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00958165
First Posted: August 13, 2009
Last Update Posted: August 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CardioFocus
  Purpose
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).

Condition Intervention Phase
Paroxysmal Atrial Fibrillation Device: CardioFocus EAS-AC Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CFEAS- AC) for the Treatment of Symptomatic Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by CardioFocus:

Primary Outcome Measures:
  • Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period. [ Time Frame: 12 months ]

Enrollment: 81
Study Start Date: August 2009
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EAS-AC
PVI with EAS-AC
Device: CardioFocus EAS-AC
PVI for PAF

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958165


Locations
Germany
Cardioangiologisches Centrum Bethanien - CCB
Frankfurg, Germany, 60431
St. Georg Hosptial
Hamburg, Germany, 20099
Universität Leipzig - Herzzentrum
Leipzig, Germany, 04289
Sponsors and Collaborators
CardioFocus
  More Information

Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT00958165     History of Changes
Other Study ID Numbers: 25-2738
First Submitted: August 12, 2009
First Posted: August 13, 2009
Results First Submitted: April 18, 2016
Results First Posted: July 27, 2016
Last Update Posted: August 30, 2016
Last Verified: July 2016

Keywords provided by CardioFocus:
Treatment of PAF using EAS-AC

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes