Sustained Monomorphic Ventricular TachycardiaNCT02274168
Utility of ICD Electrograms During Ventricular Tachycardia Ablation
A study testing Conventional RF catheter ablation and Investigational RF Catheter Ablation using ICD-EG information in people with Sustained Monomorphic Ventricular Tachycardia, run by Fundación Hospital de Madrid at 14 sites in Spain.
Trial summary
With the increasing use of implantable cardioverter defibrillators (ICD) for primary prevention in patients with structural heart disease, an increasing number of patients are expected to develop their first episode of monomorphic ventricular tachycardia (VT) after an ICD is in place and the only documentation of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sustained Monomorphic Ventricular Tachycardia
- What is being tested?
- Conventional RF catheter ablation and Investigational RF Catheter Ablation using ICD-EG information
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 14 sitesSpain
- Study dates
- Apr 2011to Mar 2022
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 years or older
- Clinical indication for RF catheter ablation
- Presence of an implanted ICD
- At least 1 episode of spontaneous sustained monomorphic VT documented with ICD electrogram
- Presence of structural heart disease
- Able to obtain signed informed consent and willing to comply with study activity requirements
Who cannot join
- It is anticipated that data can not be obtained during follow-up
- Unwilling or unable to provide informed consent
- Women who are or may potentially be pregnant
- Patients who are participating in another clinical trial
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Hospital General Universitario
Alicante
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital del Mar
Barcelona
Hospital Universitario de Basurto
Bilbao
Hospital Universitario de Burgos
Burgos
Hospital Universitario Virgen de las Nieves
Granada
Hospital Universitario Insular de Gran Canaria
Las Palmas
HM Hospitales
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Universitario Virgen de la Arrixaca
Murcia
Hospital Universitario Nuestra Señora de Valme
Seville
Hospital Virgen de la Salud
Toledo
Hospital Clínico Universitario
Valencia
About this study
Official title: Aid of Recording ICD Electrograms During Monomorphic Ventricular Tachycardia Ablation Procedures
With the increasing use of implantable cardioverter defibrillators (ICD) for primary prevention in patients with structural heart disease, an increasing number of patients are expected to develop their first episode of monomorphic ventricular tachycardia (VT) after an ICD is in place and the only documentation of the clinical arrhythmia will be the ICD electrogram (EG). The absence of a 12-lead ECG in patients with an ICD and sustained monomorphic VT represents a limitation when performing treatment with radiofrequency (RF) ablation. The analysis of ICD-EG during a RF ablation procedure is expected to provide a reference "model" of VT with clinical expression consisting of the electrical signal of the ICD during VT (which otherwise is not generally possible to obtain in ICD patients). This will allow for a more targeted approach to the substrate of the VT with clinical expression because: 1) if VT is induced by programmed stimulation, one can tell whether it is with clinical expression or not, and 2) if VT is not induced, ventricular pacing could be performed based on the comparative analysis of morphology and activation times of ICD-EG. These approaches will result in improved outcomes of the ablation procedure.
- Being tested
- Conventional RF catheter ablation, Investigational RF Catheter Ablation using ICD-EG information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional RF catheter ablationProcedure or surgery
RF catheter ablation will be performed as usually done by each center. No ICD EGMs will be obtained and used during the ablation procedure (do not place the programming head over the ICD generator).
Investigational RF Catheter Ablation using ICD-EG informationProcedure or surgery
RF ablation procedure will be performed with the programming head over the ICD generator. ICD EGMs will be registered every time VT is induced and during ventricular pacing. ICD EGMs obtained during ablation procedure will be compared with the EGMs of the registered spontaneus VT and used to locate appropriate ablation sites.
| Study group | Role | What they receive |
|---|---|---|
| Conventional RF catheter ablation | Other | Conventional RF ablation will be performed without using ICD-EG information Receives: Procedure: Conventional RF catheter ablation |
| Investigational RF Catheter Ablation using ICD-EG information | Other | RF Catheter Ablation will be performed using ICD-EG information Receives: Procedure: Investigational RF Catheter Ablation using ICD-EG information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients free of VT recurrence
Measured: 6 months
Secondary outcomes (4)
Reduction in number of VT recurrence
Measured: 6 months
Reduction in the proportion of patients free of VT recurrence
Measured: 6 months
Reduction in the proportion of patients free of recurrence in patients in whom 12-lead ECG of the spontaneous VT is not available and in those in whom hemodinamically tolerated VT is not induced
Measured: 6 months and total follow-up
Improvement of spatial resolution of the ICD-EG after information from local ventricular endocardial acceleration is added
This outcome will be studied from the stored signal together with the ICD-EG on the device in the subgroup of patients with a device that allows to obtain this parameter. In the remaining patients, signals will be obtained noninvasively with a seismocardiogram using a highly sensitive accelerometer located in the sternal midline of the xiphoid process and simultaneously synchronized with the ECG.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startApr 2011
- Primary completionMar 2022
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sustained Monomorphic Ventricular TachycardiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Hospital de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesus Almendral, MD, Study director, HM hospitales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274168
- Sponsor's protocol ID
- AIDEG-VTA
- Status last verified
- Dec 2022
- First submitted
- 14 Sep 2014
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yoshida K, Liu TY, Scott C, Hero A, Yokokawa M, Gupta S, Good E, Morady F, Bogun F. The value of defibrillator electrograms for recognition of clinical ventricular tachycardias and for pace mapping of post-infarction ventricular tachycardia. J Am Coll Cardiol. 2010 Sep 14;56(12):969-79. doi: 10.1016/j.jacc.2010.04.043.
PubMed 20828650Almendral J, Marchlinski F. Is it the same or a different ventricular tachycardia?: an additional use for defibrillator electrograms. J Am Coll Cardiol. 2010 Sep 14;56(12):980-2. doi: 10.1016/j.jacc.2010.03.081. No abstract available.
PubMed 20828651Almendral J, Atienza F, Everss E, Castilla L, Gonzalez-Torrecilla E, Ormaetxe J, Arenal A, Ortiz M, Sanroman-Junquera M, Mora-Jimenez I, Bellon JM, Rojo JL. Implantable defibrillator electrograms and origin of left ventricular impulses: an analysis of regionalization ability and visual spatial resolution. J Cardiovasc Electrophysiol. 2012 May;23(5):506-14. doi: 10.1111/j.1540-8167.2011.02233.x. Epub 2011 Dec 8.
PubMed 22151407
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aid of Recording ICD Electrograms During Monomorphic Ventricular Tachycardia Ablation Procedures
- ClinicalTrials.gov ID
- NCT02274168
- Acronym / sponsor ID
- AIDEG-VTA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Fundación Hospital de MadridUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 24 Oct 2014 (estimated)
- 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.
With the increasing use of implantable cardioverter defibrillators (ICD) for primary prevention in patients with structural heart disease, an increasing number of patients are expected to develop their first episode of monomorphic ventricular tachycardia (VT) after an ICD is in place and the only documentation of the clinical arrhythmia will be the ICD electrogram (EG). The absence of a 12-lead ECG in patients with an ICD and sustained monomorphic VT represents a limitation when performing treatment with radiofrequency (RF) ablation. The analysis of ICD-EG during a RF ablation procedure is expected to provide a reference "model" of VT with clinical expression consisting of the electrical signal of the ICD during VT (which otherwise is not generally possible to obtain in ICD patients). This will allow for a more targeted approach to the substrate of the VT with clinical expression because: 1) if VT is induced by programmed stimulation, one can tell whether it is with clinical expression or not, and 2) if VT is not induced, ventricular pacing could be performed based on the comparative analysis of morphology and activation times of ICD-EG. These approaches will result in improved outcomes of the ablation procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional RF catheter ablation | Other | Procedure: Conventional RF catheter ablationConventional RF ablation will be performed without using ICD-EG information |
| Investigational RF Catheter Ablation using ICD-EG information | Other | Procedure: Investigational RF Catheter Ablation using ICD-EG informationRF Catheter Ablation will be performed using ICD-EG information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Clinical indication for RF catheter ablation
- Presence of an implanted ICD
- At least 1 episode of spontaneous sustained monomorphic VT documented with ICD electrogram
- Presence of structural heart disease
Key exclusion criteria (4 listed)
- It is anticipated that data can not be obtained during follow-up
- Unwilling or unable to provide informed consent
- Women who are or may potentially be pregnant
- Patients who are participating in another clinical trial
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 |
|---|---|---|
| Conventional RF catheter ablationRF catheter ablation will be performed as usually done by each center. No ICD EGMs will be obtained and used during the ablation procedure (do not place the programming head over the ICD generator). | Procedure or surgery | Conventional RF catheter ablation |
| Investigational RF Catheter Ablation using ICD-EG informationRF ablation procedure will be performed with the programming head over the ICD generator. ICD EGMs will be registered every time VT is induced and during ventricular pacing. ICD EGMs obtained during ablation procedure will be compared with the EGMs of the registered spontaneus VT and used to locate appropriate ablation sites. | Procedure or surgery | Investigational RF Catheter Ablation using ICD-EG information |
Primary outcome
Percentage of patients free of VT recurrence
Time frame: 6 months
4 secondary outcomes
Reduction in number of VT recurrence
Time frame: 6 months
Reduction in the proportion of patients free of VT recurrence
Time frame: 6 months
Reduction in the proportion of patients free of recurrence in patients in whom 12-lead ECG of the spontaneous VT is not available and in those in whom hemodinamically tolerated VT is not induced
Time frame: 6 months and total follow-up
Improvement of spatial resolution of the ICD-EG after information from local ventricular endocardial acceleration is added
Time frame: 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 13 Dec 2022.
- Background: PubMed 20828650Yoshida K, Liu TY, Scott C, Hero A, Yokokawa M, Gupta S, Good E, Morady F, Bogun F. The value of defibrillator electrograms for recognition of clinical ventricular tachycardias and for pace mapping of post-infarction ventricular tachycardia. J Am Coll Cardiol. 2010 Sep 14;56(12):969-79. doi: 10.1016/j.jacc.2010.04.043.
- Background: PubMed 20828651Almendral J, Marchlinski F. Is it the same or a different ventricular tachycardia?: an additional use for defibrillator electrograms. J Am Coll Cardiol. 2010 Sep 14;56(12):980-2. doi: 10.1016/j.jacc.2010.03.081. No abstract available.
- Background: PubMed 22151407Almendral J, Atienza F, Everss E, Castilla L, Gonzalez-Torrecilla E, Ormaetxe J, Arenal A, Ortiz M, Sanroman-Junquera M, Mora-Jimenez I, Bellon JM, Rojo JL. Implantable defibrillator electrograms and origin of left ventricular impulses: an analysis of regionalization ability and visual spatial resolution. J Cardiovasc Electrophysiol. 2012 May;23(5):506-14. doi: 10.1111/j.1540-8167.2011.02233.x. Epub 2011 Dec 8.
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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.
Jesus Almendral, MD study director
HM hospitales
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional RF catheter ablation and Investigational RF Catheter Ablation using ICD-EG information in people with Sustained Monomorphic Ventricular Tachycardia, run by Fundación Hospital de Madrid at 14 sites in Spain.
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 6 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: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. 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?
Percentage of patients free of VT recurrence (time frame: 6 months). 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 NCT02274168, which also lists 3 linked publications.
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 13 Dec 2022.