Ventricular Tachycardia (V-Tach)NCT04477499
Parallel Mapping for Ventricular Tachycardia
An observational study of Ventricular Tachycardia (V-Tach) and Implantable Cardioverter Defibrillator (ICD), run by The Cleveland Clinic at 1 site in United States.
Trial summary
Catheter ablation in patients with ventricular tachycardia using a new mapping algorithm called, parallel mapping, that is aimed to increase the specificity of mapping and the outcome of ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia (V-Tach), Implantable Cardioverter Defibrillator (ICD), Arrythmia
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to 30 Dec 2022
- 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: Patients with history of scar-mediated recurrent ventricular tachycardia, who had failed therapy with anti arrhythmic drugs. All patients are planned to undergo catheter ablation procedure for ventricular tachycardia as part of the usual clinical care. All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity.
Who may be able to join
- Age ≥18 years
- History of scar-mediated sustained ventricular tachycardia
- Failure of therapy with Anti arrhythmic drugs
- Implanted ICD or a plan for ICD implantation after the ablation
- Willingness to adhere to the study restrictions and comply with all post procedural follow-up requirements
- Ability to understand the requirements of the study and sign an informed consent
Who cannot join
- Patients with reversible causes of ventricular tachycardia including ongoing ischemia or electrolyte abnormalities
- Contraindication to anticoagulation therapy
- Stroke within 30 days before enrollment
- Life expectancy <1 year
- Individual has a known, unresolved history of drug use or alcohol dependency lacks the ability to comprehend or follow instructions or would be unlikely or unable to comply with study follow-up requirements
- Pregnant or breast feeding at time of signing consent
- Patient undergoing cardiac transplantation
- Enrolled or participates in other drug or device studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ablation of Ventricular Tachycardia Guided by Multi-site Pacing Using Parallel Mapping
Catheter ablation in patients with ventricular tachycardia using a new mapping algorithm called, parallel mapping, that is aimed to increase the specificity of mapping and the outcome of ablation.
Read the detailed description
In patients with scar in the hearts after heart attacks, the risk for dangerous abnormal heart rhythms, including sudden death is high. This is because dead muscle fibers are replaced by scar tissue, creating a physiological condition promoting abnormal heart rhythms.These abnormal heart rhythms are called ventricular arrhythmias or ventricular tachycardias. In these patients, ablation procedures can be helpful, however the recurrence rate of arrhythmias after ablation remains unacceptably high. The primary reason for this high recurrence rate is nonspecific mapping methodologies for identifying the heart area responsible for these arrhythmias. Therefore, new methods for increasing the specificity of mapping have been the subject of significant research for many years, however implementation of these methods in clinical practice has been challenged by limited technologies. Recently, a new mapping technology named "parallel mapping" has been developed, received FDA approval and is routinely utilized at the Cleveland Clinic. However, the workflow of using parallel mapping, and the efficacy of ablation using this technology have not been evaluated.
- Medical subject headings
- Tachycardia, Ventricular, Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Single procedure freedom from ventricular recurrence at 1 year
Number of VT
Measured: 12 months
Secondary outcomes (3)
Freedom from implantable cardioverter defibrillator (ICD) shocks
Number of ICD shocks
Measured: 12 months
Reduction in mapping time using parallel mapping algorithm
Minutes
Measured: 12 months
Reduction in radiofrequency ablation time
Minutes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start15 Jul 2020
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Tachycardia (V-Tach)Studies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Principal investigator, Jakub Sroubek, The Cleveland Clinic
- Investigators
- Jakub Sroubek, MD, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477499
- Sponsor's protocol ID
- IRB 20-470
- Status last verified
- Jan 2023
- First submitted
- 15 Jul 2020
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation of Ventricular Tachycardia Guided by Multi-site Pacing Using Parallel Mapping
- ClinicalTrials.gov ID
- NCT04477499
- Acronym / sponsor ID
- IRB 20-470
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 20 Jul 2020 (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.
Catheter ablation in patients with ventricular tachycardia using a new mapping algorithm called, parallel mapping, that is aimed to increase the specificity of mapping and the outcome of ablation.
Detailed description
In patients with scar in the hearts after heart attacks, the risk for dangerous abnormal heart rhythms, including sudden death is high. This is because dead muscle fibers are replaced by scar tissue, creating a physiological condition promoting abnormal heart rhythms.These abnormal heart rhythms are called ventricular arrhythmias or ventricular tachycardias. In these patients, ablation procedures can be helpful, however the recurrence rate of arrhythmias after ablation remains unacceptably high. The primary reason for this high recurrence rate is nonspecific mapping methodologies for identifying the heart area responsible for these arrhythmias. Therefore, new methods for increasing the specificity of mapping have been the subject of significant research for many years, however implementation of these methods in clinical practice has been challenged by limited technologies. Recently, a new mapping technology named "parallel mapping" has been developed, received FDA approval and is routinely utilized at the Cleveland Clinic. However, the workflow of using parallel mapping, and the efficacy of ablation using this technology have not been evaluated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with history of scar-mediated recurrent ventricular tachycardia, who had failed therapy with anti arrhythmic drugs. All patients are planned to undergo catheter ablation procedure for ventricular tachycardia as part of the usual clinical care. All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity.
Key inclusion criteria (6 listed)
- Age ≥18 years
- History of scar-mediated sustained ventricular tachycardia
- Failure of therapy with Anti arrhythmic drugs
- Implanted ICD or a plan for ICD implantation after the ablation
- Willingness to adhere to the study restrictions and comply with all post procedural follow-up requirements
Key exclusion criteria (8 listed)
- Patients with reversible causes of ventricular tachycardia including ongoing ischemia or electrolyte abnormalities
- Contraindication to anticoagulation therapy
- Stroke within 30 days before enrollment
- Life expectancy <1 year
- Individual has a known, unresolved history of drug use or alcohol dependency lacks the ability to comprehend or follow instructions or would be unlikely or unable to comply with study follow-up requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Single procedure freedom from ventricular recurrence at 1 year
Time frame: 12 months
Number of VT
3 secondary outcomes
Freedom from implantable cardioverter defibrillator (ICD) shocks
Time frame: 12 months
Reduction in mapping time using parallel mapping algorithm
Time frame: 12 months
Reduction in radiofrequency ablation time
Time frame: 12 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 10 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Jakub Sroubek, MD, PhD principal investigator
The Cleveland Clinic
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 (V-Tach) and Implantable Cardioverter Defibrillator (ICD), run by The Cleveland Clinic at 1 site in United States.
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 8 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 10 Jan 2023. 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 United States. 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?
Single procedure freedom from ventricular recurrence at 1 year (time frame: 12 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 10 Jan 2023.