Substrate Ablation Guided by Automatic High Density Mapping for the Treatment of Atrial Fibrillation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 152
- Locations
- 3
- Primary Endpoint
- Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure
Study Overview
Brief Summary
To evaluate a new AF Substrate mapping method based on automatic high density CFAE detection with a multipolar catheter (Pentaray) and the " SCI 30-40 " setting of CARTO CFAE algorithm.
Detailed Description
This study is observational :
This substrate ablation method is performed routinely in the centers involved in the study so, patients were not assigned by the investigators to undergo a specific procedure because of the study, in all cases patient would have beneficiate from this substrate mapping ablation method.
We assessed procedural and follow up outcomes of this subatrate ablation group and compared them with an historical control group undergoing conventional ablation.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient from 18 to 85, with AF* (paroxysmal, and persistent AF) and indication of AF ablation (including redos)* *In accordance with the recommendation of European Society of Cardiology (2010).
Exclusion Criteria
- •organized atrial activity (Atrial tachycardia or Flutter)
Outcomes
Primary Outcomes
Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure
Time Frame: up to 240 min
percentage of patient in sinus rhythm or in atrial tachycardia at the end of the procedure
Secondary Outcomes
- Maximum Sustained AF Duration(from first AF episode to baseline)
- % of Patients With Sinus Rhythm Conversion During the Procedure(180 min)
- Radiofrequency Time (Min)(up to 300 min)
- Mean LA Volume(baseline)
- Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation(18 Months post ablation)
- Number of Patients With Major Adverse Events During and up to 18 Months After Procedure(18 months post ablation)
- Spontaneous AF at the Beginning of the Procedure(baseline)
Investigators
SEITZ JULIEN
MD , Cardiologist Rythmologist
Hospital St. Joseph, Marseille, France