Ventricular TachycardiaNCT03453645
Modification of Rhythmic Risk Assessment by Ventricular Tachycardia Ablation
An observational study of Ventricular Tachycardia, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Sudden cardiac death is a frequent cause of cardiovascular mortality. Numerous rhythmic risk assessment criterion have been described targeting the substratum, the cardiac nervous tone or the trigger of arrhythmias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- ventricular tachycardia ablation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2017to Feb 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people wich an Ventricular Tachycardia Ablation necessary and programed
Who may be able to join
- Patients undergoing ventricular tachycardia,
- patients with ischemic cardiomyopathy according to European Society of Cardiology Guidelines,
- patients with implanted cardiac defibrillator.
Who cannot join
- Contra-indication to stress test,
- permanent atrial fibrillation,
- permanent ventricular pacing,
- left bundle block.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Toulouse
Toulouse, 31000
Philippe MAURY, MD, 05 61 32 31 00, maury.p@chu-toulouse.fr
About this study
Sudden cardiac death is a frequent cause of cardiovascular mortality. Numerous rhythmic risk assessment criterion have been described targeting the substratum, the cardiac nervous tone or the trigger of arrhythmias. Development of ventricular tachycardia ablation in the past few years show interesting results preventing the recurrence of ventricular arrhythmias.
Read the detailed description
Sudden cardiac death is a frequent cause of cardiovascular mortality. Numerous rhythmic risk assessment criterion have been described targeting the substratum, the cardiac nervous tone or the trigger of arrhythmias. Development of ventricular tachycardia ablation in the past few years show interesting results preventing the recurrence of ventricular arrhythmias.
Rhythmic risk assessment criterions have never been studied in relation with ventricular tachycardia ablation. The purpose of this study is to explore the modifications of these criterions after ventricular tachycardia ablation.
- Conditions
- Ventricular Tachycardia
- Being tested
- ventricular tachycardia ablation
- Keywords
- ablation, sudden death, signal averaged ECG, T wave alternans, heart rate variability
- Medical subject headings
- Tachycardia, Ventricular, Death, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventricular tachycardia ablationProcedure or surgery
The usual organization of hospitalization of the patients addressed for ventricular tachycardia ablation and his follow-up are not modified by the protocol. .
What is being measured
The primary outcome is the main question the study is designed to answer.
measure assessing change before and after Ventricular Tachycardia Ablation of the non-invasive parameters analysis of the rhythmic risk before and after Ventricular Tachycardia Ablation
non invasive parameters analysis of the rhythmic risk will be evaluated by the evaluation of the T wave alternans
Measured: 10 minutes and 60 minutes after the Ventricular Tachycardia Ablation
Secondary outcomes (2)
Assessing the correlations of the modifications of the risk criterion after ablation with the recurrences of arrhythmias at one year follow-up
the recurrences of arrhythmias will be evaluated . There will be assessed by the informations reveled by the Implantable automatic defibrillator
Measured: 3 months, 6 months and 12 months after the Ventricular Tachycardia Ablation
Study of the correlation between the modifications of non-invasive parameters analysis of the rhythmic risk and the success of the ablation procedure
Success of the ablation procedure is defined by the absence of inducible Ventricular Tachycardia at the end of the procedure.
Measured: 3 months, 6 months and 12 months after the Ventricular Tachycardia Ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start9 Sep 2017
- Primary completionSep 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe MAURY, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453645
- Sponsor's protocol ID
- RC31/17/0066
- Other IDs
- 2017-A00582-51
- Status last verified
- Jul 2018
- First submitted
- 27 Jul 2017
- Last updated
- 11 Jul 2018
- 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 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of Rhythmic Risk Assessment by Ventricular Tachycardia Ablation
- ClinicalTrials.gov ID
- NCT03453645
- Acronym / sponsor ID
- RC31/17/0066
- Conditions
- Ventricular Tachycardia
- Keywords
- ablation, sudden death, signal averaged ECG, T wave alternans, heart rate variability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 9 Sep 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 5 Mar 2018 (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.
Sudden cardiac death is a frequent cause of cardiovascular mortality. Numerous rhythmic risk assessment criterion have been described targeting the substratum, the cardiac nervous tone or the trigger of arrhythmias. Development of ventricular tachycardia ablation in the past few years show interesting results preventing the recurrence of ventricular arrhythmias.
Detailed description
Sudden cardiac death is a frequent cause of cardiovascular mortality. Numerous rhythmic risk assessment criterion have been described targeting the substratum, the cardiac nervous tone or the trigger of arrhythmias. Development of ventricular tachycardia ablation in the past few years show interesting results preventing the recurrence of ventricular arrhythmias.
Rhythmic risk assessment criterions have never been studied in relation with ventricular tachycardia ablation. The purpose of this study is to explore the modifications of these criterions after ventricular tachycardia ablation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people wich an Ventricular Tachycardia Ablation necessary and programed
Key inclusion criteria (3 listed)
- Patients undergoing ventricular tachycardia,
- patients with ischemic cardiomyopathy according to European Society of Cardiology Guidelines,
- patients with implanted cardiac defibrillator.
Key exclusion criteria (4 listed)
- Contra-indication to stress test,
- permanent atrial fibrillation,
- permanent ventricular pacing,
- left bundle block.
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 |
|---|---|---|
| ventricular tachycardia ablationThe usual organization of hospitalization of the patients addressed for ventricular tachycardia ablation and his follow-up are not modified by the protocol. . | Procedure or surgery | – |
Primary outcome
measure assessing change before and after Ventricular Tachycardia Ablation of the non-invasive parameters analysis of the rhythmic risk before and after Ventricular Tachycardia Ablation
Time frame: 10 minutes and 60 minutes after the Ventricular Tachycardia Ablation
non invasive parameters analysis of the rhythmic risk will be evaluated by the evaluation of the T wave alternans
2 secondary outcomes
Assessing the correlations of the modifications of the risk criterion after ablation with the recurrences of arrhythmias at one year follow-up
Time frame: 3 months, 6 months and 12 months after the Ventricular Tachycardia Ablation
Study of the correlation between the modifications of non-invasive parameters analysis of the rhythmic risk and the success of the ablation procedure
Time frame: 3 months, 6 months and 12 months after the Ventricular Tachycardia Ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
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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.
Philippe MAURY, MD principal investigator
University Hospital of Toulouse
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 Ventricular Tachycardia, run by University Hospital, Toulouse 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe MAURY, MD (05 61 32 31 00, maury.p@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure assessing change before and after Ventricular Tachycardia Ablation of the non-invasive parameters analysis of the rhythmic risk before and after Ventricular Tachycardia Ablation (time frame: 10 minutes and 60 minutes after the Ventricular Tachycardia Ablation). 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 11 Jul 2018.