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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT00958165
First received: August 12, 2009
Last updated: June 19, 2012
Last verified: June 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT00958165     History of Changes
Other Study ID Numbers: 25-2738
Study First Received: August 12, 2009
Last Updated: June 19, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on July 20, 2014