Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation (SUBSTRATE-HD)

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Routine substrate ablation without pulmonary vein Isolation; Procedure: Routine conventional ablation with pulmonary vein Isolation

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 Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13008
    • Hopital Saint Joseph
  • Nice, France
    • CHU
  • Paris, France
    • Institut Mutualiste de Montsouris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Studied; Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation	Procedure: Routine substrate ablation without pulmonary vein Isolation
Control; The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.	Procedure: Routine conventional ablation with pulmonary vein Isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of Patients With Sinus Rhythm Conversion During the Procedure		180 min
Radiofrequency Time (Min)		up to 300 min
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
Number of Patients With Major Adverse Events During and up to 18 Months After Procedure	Adverse events	18 months post ablation
Maximum Sustained AF Duration	duration of the longest AF epiodes in months before ablation	from first AF episode to baseline
Mean LA Volume	Left Atrial volume before ablation in ml	baseline
Spontaneous AF at the Beginning of the Procedure	Spontaneous AF at the beginning of the procedure	baseline

Collaborators and Investigators

• Sponsor: Hospital St. Joseph, Marseille, France
• Investigators: Principal Investigator: Julien Seitz, MD, St Joseph hospital Marseille

Publications and helpful links

General Publications

• Seitz J, Bars C, Theodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: March 14, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (Estimate): March 21, 2014

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: SUBSTRATE-HD