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CompletedNCT02093949SUBSTRATE-HDUpdated Nov 6, 2017Results posted

Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation

An observational study in Atrial Fibrillation, sponsored by Hospital St. Joseph, Marseille, France. Completed at 3 sites in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-11-06.

Sponsored by Hospital St. Joseph, Marseille, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
152
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 152 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Hospital St. Joseph, Marseille, France is the lead sponsor of 31 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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).

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

Exclusion Criteria:

  • organized atrial activity (Atrial tachycardia or Flutter)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
152 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • ProcedureRoutine substrate ablation without pulmonary vein Isolation
  • ProcedureRoutine conventional ablation with pulmonary vein Isolation
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 240 min

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

    % of patients in sinus rhythm or in atrial tachycardia assessed by ECG and/ot 24h-Holter monitoring and clinical examination during follow-up.

    Time frame: 18 Months post ablation

  4. Number of Patients With Major Adverse Events During and up to 18 Months After Procedure

    Adverse events

    Time frame: 18 months post ablation

  5. Maximum Sustained AF Duration

    duration of the longest AF epiodes in months before ablation

    Time frame: from first AF episode to baseline

  6. Mean LA Volume

    Left Atrial volume before ablation in ml

    Time frame: baseline

  7. Spontaneous AF at the Beginning of the Procedure

    Spontaneous AF at the beginning of the procedure

    Time frame: baseline

07

Results

Posted May 3, 2017

Participant flow

Participant flow — Overall Study
MilestoneSubstrate AblationHistorical Control
Started10547
Completed10547
Not completed00

Outcome measures

PrimaryPercentage 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

Time frame:
up to 240 min
Reported as:
Number · Percentage of participants
Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure
Percentage of participantsSubstrate AblationHistorical Control
Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure9560
Secondary% of Patients With Sinus Rhythm Conversion During the Procedure
Time frame:
180 min
Reported as:
Number · % of participants
% of Patients With Sinus Rhythm Conversion During the Procedure
% of participantsSubstrate AblationHistorical Control
% of Patients With Sinus Rhythm Conversion During the Procedure7126
SecondaryRadiofrequency Time (Min)
Time frame:
up to 300 min
Reported as:
Number · min
Radiofrequency Time (Min)
minSubstrate AblationHistorical Control
Radiofrequency Time (Min)49.184.6
SecondaryPercentage 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.

Time frame:
18 Months post ablation
Reported as:
Number · % of participants
Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation
% of participantsSubstrate Ablation Long Term Follow UpHistorical Control Long Term Follow-up
Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation8942
SecondaryNumber of Patients With Major Adverse Events During and up to 18 Months After Procedure

Adverse events

Time frame:
18 months post ablation
Reported as:
Number · participants
Number of Patients With Major Adverse Events During and up to 18 Months After Procedure
participantsSubstrate Ablation Long Term Follow-upHistorical Control Long Term Follow-up
Number of Patients With Major Adverse Events During and up to 18 Months After Procedure11
SecondaryMaximum Sustained AF Duration

duration of the longest AF epiodes in months before ablation

Time frame:
from first AF episode to baseline
Reported as:
Number · months
Maximum Sustained AF Duration
monthsSubstrate AblationHistorical Control
Maximum Sustained AF Duration12.219.4
SecondaryMean LA Volume

Left Atrial volume before ablation in ml

Time frame:
baseline
Reported as:
Mean · ml
Mean LA Volume
mlSubstrate Ablation
Mean LA Volume168 ± 45
SecondarySpontaneous AF at the Beginning of the Procedure

Spontaneous AF at the beginning of the procedure

Time frame:
baseline
Reported as:
Count of participants · Participants
Spontaneous AF at the Beginning of the Procedure
ParticipantsSubstrate Ablation
Spontaneous AF at the Beginning of the Procedure65

Adverse events

Collected over from ablation to 18 month follow up. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Substrate Ablation—1/105 (1%)0/105 (0%)
Historical Control—0/47 (0%)0/47 (0%)
Most frequent serious events
Most frequent serious events
EventSubstrate AblationHistorical Control
Redo Pericardial effusionCardiac disorders1/1050/47

Baseline characteristics

Age, Continuous
Age, Continuous(year)Substrate AblationHistorical ControlTotal
Mean63 ± 1158 ± 1161 ± 13
Sex: Female, Male
Sex: Female, Male(Participants)Substrate AblationHistorical ControlTotal
Female251237
Male8035115
Paroxysmal AF
Paroxysmal AF(participants)Substrate AblationHistorical ControlTotal
Number24933
Nonparoxysmal AF
Nonparoxysmal AF(participants)Substrate AblationHistorical ControlTotal
Number8138119
Structural heart disease
Structural heart disease(participants)Substrate AblationHistorical ControlTotal
Number381452
Hypertension
Hypertension(participants)Substrate AblationHistorical ControlTotal
Number482068
Diabetes
Diabetes(participants)Substrate AblationHistorical ControlTotal
Number13518
08

Study locations

3 sites
  • Hopital Saint Joseph
    Marseille, 13008, France
  • CHU
    Nice, France
  • Institut Mutualiste de Montsouris
    Paris, France
09

References and documents

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. PubMed 28104073 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02093949
Lead sponsor
Hospital St. Joseph, Marseille, France
Responsible party
SEITZ JULIEN (MD , Cardiologist Rythmologist, Hospital St. Joseph, Marseille, France) — Principal investigator
First posted
Mar 21, 2014
Start date
Sep 2013
Primary completion
Dec 2014
Completion
Aug 2016
Results posted
May 3, 2017
Last update
Nov 6, 2017

Study contacts

Julien Seitz, MD
principal investigator · St Joseph hospital Marseille

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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