Atrial FibrillationASEPAFNCT03937089
Analysis of Endocavitary Electrical Signal and Surface Electrocardiogram to Predict Ablation Outcome in Persistent Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Background : Despite recent progress in the management of patients with Atrial Fibrillation (AF), AF remains one of the main risk factor of stroke, heart failure and cardiovascular mortality in the world. AF is the most common cardiac arrhythmia, and its prevalence is expected to grow in the coming years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Data collection
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with persistent AF, who underwent a CA procedure in the Nancy hospital between January 2011 and April 2017, will be included in this retrospective study.
Who may be able to join
- Patients for which clinical data, along with the ECG signals before and during the CA procedure are available,
- Patients who underwent a first ablation procedure for persistent AF
Who cannot join
- ECG data is not interpretable
- Patients who underwent a second or umpteenth ablation procedure for persistent AF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Endocavitary Electrical Signal and Surface Electrocardiogram to Determine Relevant Features for an Accurate Prediction of Ablation Outcome for Patients in Persistent Atrial Fibrillation
Background :
Despite recent progress in the management of patients with Atrial Fibrillation (AF), AF remains one of the main risk factor of stroke, heart failure and cardiovascular mortality in the world. AF is the most common cardiac arrhythmia, and its prevalence is expected to grow in the coming years.
Read more
Catheter ablation (CA) of AF can be successful in restoring and maintaining Sinus rhythm (SR) in patients with paroxysmal, and persistent AF. Haissaguerre et al. have shown that AF ablation of the heart by isolating the Pulmonary Vein is usually sufficient. However, when ablating persistent AF patients ablating pathological regions in the atria is also required. CA is still a challenging procedure, and reported success rate for persistent AF patients remains relatively low (around 60%). This procedure is associated with risks inherent to any invasive cardiac procedures.
A better identification of good responders would reduce the risks associated with ablation, especially for patients with low odds of favorable outcome, while also increasing the success rate of the procedure. It has been shown in the literature the long-term CA outcome can be predicted non-invasively by atrial fibrillatory wave (f-wave) amplitudes.
Hypothesis :
We assume that a morphological analysis of the f-waves on standard twelve ECG will allow for a better CA outcome prediction.
Objectives :
The aim of this study is to automatically analyse the morphology of the ECG signal before a CA procedure, extract relevant features for an accurate prediction of long-term CA outcome for patients in persistent AF.
- Conditions
- Atrial Fibrillation
- Being tested
- Data collection
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection from medical file
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with persistent AF, who underwent a CA procedure in the Nancy hospital between January 2011 and April 2017, will be included in this retrospective study. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the f-waves on ECG
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start24 May 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937089
- Sponsor's protocol ID
- PSS2018/ASEPAF-SELLAL/YB
- Acronym
- ASEPAF
- Status last verified
- Oct 2018
- First submitted
- 8 Apr 2019
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Endocavitary Electrical Signal and Surface Electrocardiogram to Determine Relevant Features for an Accurate Prediction of Ablation Outcome for Patients in Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03937089
- Acronym / sponsor ID
- ASEPAF / PSS2018/ASEPAF-SELLAL/YB
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 24 May 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background :
Despite recent progress in the management of patients with Atrial Fibrillation (AF), AF remains one of the main risk factor of stroke, heart failure and cardiovascular mortality in the world. AF is the most common cardiac arrhythmia, and its prevalence is expected to grow in the coming years.
Catheter ablation (CA) of AF can be successful in restoring and maintaining Sinus rhythm (SR) in patients with paroxysmal, and persistent AF. Haissaguerre et al. have shown that AF ablation of the heart by isolating the Pulmonary Vein is usually sufficient. However, when ablating persistent AF patients ablating pathological regions in the atria is also required. CA is still a challenging procedure, and reported success rate for persistent AF patients remains relatively low (around 60%). This procedure is associated with risks inherent to any invasive cardiac procedures.
A better identification of good responders would reduce the risks associated with ablation, especially for patients with low odds of favorable outcome, while also increasing the success rate of the procedure. It has been shown in the literature the long-term CA outcome can be predicted non-invasively by atrial fibrillatory wave (f-wave) amplitudes.
Hypothesis :
We assume that a morphological analysis of the f-waves on standard twelve ECG will allow for a better CA outcome prediction.
Objectives :
The aim of this study is to automatically analyse the morphology of the ECG signal before a CA procedure, extract relevant features for an accurate prediction of long-term CA outcome for patients in persistent AF.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Data collectionPatients with persistent AF, who underwent a CA procedure in the Nancy hospital between January 2011 and April 2017, will be included in this retrospective study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with persistent AF, who underwent a CA procedure in the Nancy hospital between January 2011 and April 2017, will be included in this retrospective study.
Key inclusion criteria (2 listed)
- Patients for which clinical data, along with the ECG signals before and during the CA procedure are available,
- Patients who underwent a first ablation procedure for persistent AF
Key exclusion criteria (2 listed)
- ECG data is not interpretable
- Patients who underwent a second or umpteenth ablation procedure for persistent AF
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 |
|---|---|---|
| Data collectionData collection from medical file | Other | Patients |
Primary outcome
Analysis of the f-waves on ECG
Time frame: Through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
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Atrial Fibrillation (AF)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Central Hospital, Nancy, France at 1 site 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 2 inclusion and 2 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 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Analysis of the f-waves on ECG (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2019.