Atrial FibrillationSUBSTRATE-HDNCT02093949
Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Hospital St. Joseph, Marseille, France at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Routine substrate ablation without pulmonary vein Isolation and Routine conventional ablation with pulmonary vein Isolation
- Type of treatment
- Surgery or procedure
- How many people
- 152 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2013to Aug 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- organized atrial activity (Atrial tachycardia or Flutter)
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hopital Saint Joseph
Marseille, 13008
CHU
Nice
Institut Mutualiste de Montsouris
Paris
About this study
Official title: 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.
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Routine substrate ablation without pulmonary vein Isolation, Routine conventional ablation with pulmonary vein Isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine substrate ablation without pulmonary vein IsolationProcedure or surgery
Routine conventional ablation with pulmonary vein IsolationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: Routine conventional ablation with pulmonary vein Isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 240 min
Secondary outcomes (7)
% of Patients With Sinus Rhythm Conversion During the Procedure
Measured: 180 min
Radiofrequency Time (Min)
Measured: 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.
Measured: 18 Months post ablation
Number of Patients With Major Adverse Events During and up to 18 Months After Procedure
Adverse events
Measured: 18 months post ablation
Maximum Sustained AF Duration
duration of the longest AF epiodes in months before ablation
Measured: from first AF episode to baseline
Mean LA Volume
Left Atrial volume before ablation in ml
Measured: baseline
Spontaneous AF at the Beginning of the Procedure
Spontaneous AF at the beginning of the procedure
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEITZ JULIEN, Hospital St. Joseph, Marseille, France
- Investigators
- Julien Seitz, MD, Principal investigator, St Joseph hospital Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093949
- Sponsor's protocol ID
- SUBSTRATE-HD
- Acronym
- SUBSTRATE-HD
- Status last verified
- Oct 2017
- First submitted
- 14 Mar 2014
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substrate Ablation Guided by Automatic High Density Mapping for the Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02093949
- Acronym / sponsor ID
- SUBSTRATE-HD / SUBSTRATE-HD
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Posted 3 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Studied | – | Procedure: Routine substrate ablation without pulmonary vein IsolationBetween 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 |
| Control | – | Procedure: Routine conventional ablation with pulmonary vein IsolationThe validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- organized atrial activity (Atrial tachycardia or Flutter)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine substrate ablation without pulmonary vein Isolation | Procedure or surgery | Studied |
| Routine conventional ablation with pulmonary vein Isolation | Procedure or surgery | Control |
Primary outcome
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
7 secondary outcomes
% of Patients With Sinus Rhythm Conversion During the Procedure
Time frame: 180 min
Radiofrequency Time (Min)
Time frame: up to 300 min
Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation
Time frame: 18 Months post ablation
Number of Patients With Major Adverse Events During and up to 18 Months After Procedure
Time frame: 18 months post ablation
Maximum Sustained AF Duration
Time frame: from first AF episode to baseline
Mean LA Volume
Time frame: baseline
Spontaneous AF at the Beginning of the Procedure
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28104073Seitz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Seitz, MD principal investigator
St Joseph hospital Marseille
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Hospital St. Joseph, Marseille, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure (time frame: up to 240 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02093949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.