Back to resultsClinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
CardioFocus EAS-AC
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Treatment of PAF using EAS-AC
Eligibility 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
Sites / Locations
- Cardioangiologisches Centrum Bethanien - CCB
- St. Georg Hosptial
- Universität Leipzig - Herzzentrum
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EAS-AC
Arm Description
PVI with EAS-AC
Outcomes
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00958165
Brief Title
Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF
Official Title
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CFEAS- AC) for the Treatment of Symptomatic Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CardioFocus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Treatment of PAF using EAS-AC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EAS-AC
Arm Type
Experimental
Arm Description
PVI with EAS-AC
Intervention Type
Device
Intervention Name(s)
CardioFocus EAS-AC
Intervention Description
PVI for PAF
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cardioangiologisches Centrum Bethanien - CCB
City
Frankfurg
ZIP/Postal Code
60431
Country
Germany
Facility Name
St. Georg Hosptial
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universität Leipzig - Herzzentrum
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF
We'll reach out to this number within 24 hrs