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Completed

NCT Number: NCT02093949

Substrate Ablation Guided by High Density Mapping in 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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Saint Joseph, Marseille, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Routine substrate ablation without pulmonary vein Isolation

Procedure

Routine conventional ablation with pulmonary vein Isolation

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital St. Joseph, Marseille, France

Other

Registry information

Official study title

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

Acronym: SUBSTRATE-HD

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Mar 21, 2014
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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