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

• ClinicalTrials.gov Identifier: NCT02093949
• Recruitment Status: Completed
• First Posted: March 21, 2014
• Results First Posted: May 3, 2017
• Last Update Posted: November 6, 2017
• Sponsor: Hospital St. Joseph, Marseille, France
• Information provided by (Responsible Party): SEITZ JULIEN, Hospital St. Joseph, Marseille, France

Study Description

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.

Condition or disease	Intervention/treatment
Atrial Fibrillation	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 Design

• Study Type: Observational
• Actual Enrollment: 152 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Substrate Ablation Guided by Automatic High Density Mapping for the Treatment of Atrial Fibrillation
• Study Start Date: September 2013
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: August 2016

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. % of Patients With Sinus Rhythm Conversion During the Procedure [ Time Frame: 180 min ]
2. Radiofrequency Time (Min) [ Time Frame: up to 300 min ]
3. Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation [ Time Frame: 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.
4. Number of Patients With Major Adverse Events During and up to 18 Months After Procedure [ Time Frame: 18 months post ablation ]
   Adverse events
5. Maximum Sustained AF Duration [ Time Frame: from first AF episode to baseline ]
   duration of the longest AF epiodes in months before ablation
6. Mean LA Volume [ Time Frame: baseline ]
   Left Atrial volume before ablation in ml
7. Spontaneous AF at the Beginning of the Procedure [ Time Frame: baseline ]
   Spontaneous AF at the beginning of the procedure

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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).

Criteria

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)

Contacts and Locations

Locations

France

Hopital Saint Joseph

Marseille, France, 13008

CHU

Nice, France

Institut Mutualiste de Montsouris

Paris, France

Sponsors and Collaborators

Hospital St. Joseph, Marseille, France

Investigators

• Principal Investigator: Julien Seitz, MD; St Joseph hospital Marseille

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Seitz J, Bars C, Théodore 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.

• Responsible Party: SEITZ JULIEN, MD , Cardiologist Rythmologist, Hospital St. Joseph, Marseille, France
• ClinicalTrials.gov Identifier: NCT02093949
• Other Study ID Numbers: SUBSTRATE-HD
• First Posted: March 21, 2014
• Results First Posted: May 3, 2017
• Last Update Posted: November 6, 2017
• Last Verified: October 2017

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes