Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— SUBSTRATE-HD  

Official title:

Substrate Ablation Guided by Automatic High Density Mapping for the Treatment of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093949
• Other study ID #: SUBSTRATE-HD
• Status: Completed
• Phase: N/A
• First received: March 14, 2014
• Last updated: October 3, 2017
• Start date: September 2013
• Est. completion date: August 2016

Study information

• Verified date: October 2017
• Source: Hospital St. Joseph, Marseille, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: August 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Routine substrate ablation without pulmonary vein Isolation

• Routine conventional ablation with pulmonary vein Isolation

Locations

Country	Name	City	State
France	Hopital Saint Joseph	Marseille
France	CHU	Nice
France	Institut Mutualiste de Montsouris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hospital St. Joseph, Marseille, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure	percentage of patient in sinus rhythm or in atrial tachycardia at the end of the procedure	up to 240 min
Secondary	% of Patients With Sinus Rhythm Conversion During the Procedure		180 min
Secondary	Radiofrequency Time (Min)		up to 300 min
Secondary	Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation	% of patients in sinus rhythm or in atrial tachycardia assessed by ECG and/ot 24h-Holter monitoring and clinical examination during follow-up.	18 Months post ablation
Secondary	Number of Patients With Major Adverse Events During and up to 18 Months After Procedure	Adverse events	18 months post ablation
Secondary	Maximum Sustained AF Duration	duration of the longest AF epiodes in months before ablation	from first AF episode to baseline
Secondary	Mean LA Volume	Left Atrial volume before ablation in ml	baseline
Secondary	Spontaneous AF at the Beginning of the Procedure	Spontaneous AF at the beginning of the procedure	baseline