Ventricular TachycardiaPhase 4NCT02083016
Ultra-high Density Mapping With Multielectrode Catheter vs Conventional Point by Point Mapping for Ventricular Tachycardia Substrate Ablation
A Phase 4 study testing Ablation guided by conventional mapping. and Ablation guided by ultra-high density mapping with multielectrode catheter. in people with Ventricular Tachycardia, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Ultra-high density mapping with multielectrode catheter may improve slow conduction channels identification in ventricular tachycardia substrate ablation procedures compared to conventional point by point mapping. 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?
- Ablation guided by conventional mapping. and Ablation guided by ultra-high density mapping with multielectrode catheter.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2014to Jan 2017
- Phase
- Phase 4
- 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
- Patients with indication for ventricular tachycardia substrate ablation.
Who cannot join
- Pregnant woman.
- Reduced expectancy of life (less than 12 months)
- Patient participating in another clinical study that investigates a drug or device
- Psychologically unstable patient or denies to give informed consent
- Any cause that contraindicate ablation procedure or antiarrhythmic drug
Trial locations and contacts
1 site in 1 country.
About this study
Ultra-high density mapping with multielectrode catheter may improve slow conduction channels identification in ventricular tachycardia substrate ablation procedures compared to conventional point by point mapping.
This study compares the ability of both mapping catheters to detect slow conduction channels in areas of myocardial scar and their utility to assess substrate modification after ablation.
Read the detailed description
This is a prospective, randomized controlled study. Twenty patients with sustained ventricular tachycardia and structurally abnormal ventricle(s) will be prospectively enrolled. In all patients a detailed pre and post-ablation electroanatomical mapping will be performed, and these maps will be merged with CT and/or MRI images. Patients will be randomly assigned to two groups. In Group A patients both pre and post-ablation mapping will be performed firstly by conventional point by point mapping using a Navistar Thermocool catheter, and secondly by multielectrode contact mapping using a Pentaray catheter. In this group, target ablation sites will be guided by point by point map. In Group B patients, both pre and post-ablation mapping will be performed firstly by multielectrode contact mapping using a Pentaray catheter, and secondly by conventional point by point mapping using a Navistar Thermocool catheter. In this group target ablation sites will be guided by multielectrode contact mapping.
Slow conduction channels will be identified by color-coded voltage map adjustment of the lower and upper thresholds and also the presence of fractioned electrograms with the delayed component showing sequential orthodromic activation. The entrances of these channels will be the target of the ablation sites (scar dechanneling technique).
- Conditions
- Ventricular Tachycardia
- Being tested
- Ablation guided by conventional mapping., Ablation guided by ultra-high density mapping with multielectrode catheter.
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation guided by conventional mapping.Device
Substrate mapping and ablation of ventricular tachycardia.
Ablation guided by ultra-high density mapping with multielectrode catheter.Device
Substrate mapping and ablation of ventricular tachycardia.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Mapping | Other | Both pre and post-ablation mapping will be performed firstly by conventional point by point mapping using a Navistar Thermocool catheter, and secondly by multielectrode contact mapping using a Pentaray catheter. In this group, ablation will be guided by conventional mapping. Receives: Device: Ablation guided by conventional mapping. |
| Multielectrode mapping. | Other | Both pre and post-ablation mapping will be performed firstly by multielectrode contact mapping using a Pentaray catheter, and secondly by conventional point by point mapping using a Navistar Thermocool catheter. In this group ablation will be guided by multielectrode contact mapping. Receives: Device: Ablation guided by ultra-high density mapping with multielectrode catheter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mapping and ablation times
Mapping and ablation times with each mapping system (point by point vs multielectrode mapping).
Measured: During procedure.
Secondary outcomes (4)
Scar area correlation with MRI.
To assess the correlation between the values of scar area obtained from both electroanatomical mapping systems and those resulting from the analysis of MRI.
Measured: Immediately after intervention.
Radiofrequency delivery time.
Measured: During procedure.
Reduction of residual electrograms with delayed component.
Reduction of residual electrograms with delayed component after ablation.
Measured: Immediately after intervention.
Ventricular tachycardia inducibility after ablation.
Measured: Immediately after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionJan 2017
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Berruezo, MD, PhD, Hospital Clinic of Barcelona
- Investigators
- Juan Acosta, MD, Principal investigator, Hospital Clinic of BarcelonaDiego Penela, MD, Principal investigator, Hosptial Clínic de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083016
- Sponsor's protocol ID
- PentaRay
- Status last verified
- Feb 2017
- First submitted
- 5 Mar 2014
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-high Density Mapping With Multielectrode Catheter vs Conventional Point by Point Mapping for Ventricular Tachycardia Substrate Ablation
- ClinicalTrials.gov ID
- NCT02083016
- Acronym / sponsor ID
- PentaRay
- Conditions
- Ventricular Tachycardia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 11 Mar 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.
Ultra-high density mapping with multielectrode catheter may improve slow conduction channels identification in ventricular tachycardia substrate ablation procedures compared to conventional point by point mapping.
This study compares the ability of both mapping catheters to detect slow conduction channels in areas of myocardial scar and their utility to assess substrate modification after ablation.
Detailed description
This is a prospective, randomized controlled study. Twenty patients with sustained ventricular tachycardia and structurally abnormal ventricle(s) will be prospectively enrolled. In all patients a detailed pre and post-ablation electroanatomical mapping will be performed, and these maps will be merged with CT and/or MRI images. Patients will be randomly assigned to two groups. In Group A patients both pre and post-ablation mapping will be performed firstly by conventional point by point mapping using a Navistar Thermocool catheter, and secondly by multielectrode contact mapping using a Pentaray catheter. In this group, target ablation sites will be guided by point by point map. In Group B patients, both pre and post-ablation mapping will be performed firstly by multielectrode contact mapping using a Pentaray catheter, and secondly by conventional point by point mapping using a Navistar Thermocool catheter. In this group target ablation sites will be guided by multielectrode contact mapping.
Slow conduction channels will be identified by color-coded voltage map adjustment of the lower and upper thresholds and also the presence of fractioned electrograms with the delayed component showing sequential orthodromic activation. The entrances of these channels will be the target of the ablation sites (scar dechanneling technique).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Mapping | Other | Device: Ablation guided by conventional mapping.Both pre and post-ablation mapping will be performed firstly by conventional point by point mapping using a Navistar Thermocool catheter, and secondly by multielectrode contact mapping using a Pentaray catheter. In this group, ablation will be guided by conventional mapping. |
| Multielectrode mapping. | Other | Device: Ablation guided by ultra-high density mapping with multielectrode catheter.Both pre and post-ablation mapping will be performed firstly by multielectrode contact mapping using a Pentaray catheter, and secondly by conventional point by point mapping using a Navistar Thermocool catheter. In this group ablation will be guided by multielectrode contact mapping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with indication for ventricular tachycardia substrate ablation.
Key exclusion criteria (5 listed)
- Pregnant woman.
- Reduced expectancy of life (less than 12 months)
- Patient participating in another clinical study that investigates a drug or device
- Psychologically unstable patient or denies to give informed consent
- Any cause that contraindicate ablation procedure or antiarrhythmic drug
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 |
|---|---|---|
| Ablation guided by conventional mapping.Substrate mapping and ablation of ventricular tachycardia. | Device | Conventional Mapping |
| Ablation guided by ultra-high density mapping with multielectrode catheter.Substrate mapping and ablation of ventricular tachycardia. | Device | Multielectrode mapping. |
Primary outcome
Mapping and ablation times
Time frame: During procedure.
Mapping and ablation times with each mapping system (point by point vs multielectrode mapping).
4 secondary outcomes
Scar area correlation with MRI.
Time frame: Immediately after intervention.
Radiofrequency delivery time.
Time frame: During procedure.
Reduction of residual electrograms with delayed component.
Time frame: Immediately after intervention.
Ventricular tachycardia inducibility after ablation.
Time frame: Immediately after intervention.
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 27 Feb 2017.
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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.
Juan Acosta, MD principal investigator
Hospital Clinic of Barcelona
Diego Penela, MD principal investigator
Hosptial Clínic de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ablation guided by conventional mapping. and Ablation guided by ultra-high density mapping with multielectrode catheter. in people with Ventricular Tachycardia, run by Hospital Clinic of Barcelona at 1 site 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 1 inclusion and 5 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 27 Feb 2017. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mapping and ablation times (time frame: During procedure.). 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 27 Feb 2017.