Ventricular TachycardiaNCT04004624
Physiologically Guided VT Ablation
A study testing Ablation in people with Ventricular Tachycardia, run by Center for Cardiovascular Reseach and Innovation.
Trial summary
The purpose of this study is to determine the efficacy of VT ablation guided by functional evaluation of the substrate to specifically target the reentry-vulnerable zones in patients with infarct-related VT. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2014to 1 Jan 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- History of myocardial infarction ≥1month before enrolment documented by ECG or cardiac imaging (TTE, SPECT, CMR).
- Planned for first VT ablation procedure.
- Patients must have an ICD or a plan for ICD implantation after the ablation.
- Ability to understand the requirement of the study and to sign an informed consent.
Who cannot join
- Patients requiring long-term treatment with class I or class III antiarrhythmic drugs after ablation (for AF).
- The VT substrate is thought not to be related to coronary disease.
- Presence of ongoing ischemia that is thought to be the cause of the VT.
- Contraindication to anticoagulation therapy
- Stroke within 30 days before enrollment.
- Life expectancy <1 year for any medical condition.
About this study
Official title: Physiologically Guided Ablation of Reentry-Vulnerable-Zones for the Treatment of Post-Infarction Ventricular Tachycardia
The purpose of this study is to determine the efficacy of VT ablation guided by functional evaluation of the substrate to specifically target the reentry-vulnerable zones in patients with infarct-related VT.
Read the detailed description
Activation mapping of VT is the gold-standard method for description of the reentrant circuit and identification of its isthmus, however this is uncommonly accomplished due to hemodynamic non-tolerance and limited temporal and spatial resolution. Substrate mapping has been developed as an alternative method to identify the isthmus of post-infarction VT during sinus rhythm (SR). However, it has limited specificity to critical VT sites.
Fundamental work in animal models of healed infarction and humans has shown that the VT isthmus corresponds to locations characterized by marked activation slowing during SR. Furthermore, these locations serve as "anchors" for multiple VT morphologies and cycle lengths.
The hypothesis of this study is that activation mapping during SR or pacing can improve the specifically for identifying the critical VT sites.
The aim of this prospective, multi-center controlled study is to evaluate the utility and limitations of functional mapping for guiding ablation of reentry vulnerably zones for long-term control of VT
- Conditions
- Ventricular Tachycardia
- Being tested
- Ablation
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationDevice
Cardiac Ablation
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Active comparator | The left ventricle is mapped during atrial and right or left ventricular pacing (site close to the infarct) at a similar cycle length of 600ms. Radio-frequency ablation is performed selectively in areas of activation slowing (defined as ≤40ms per 5mm while voltage abnormalities and late potentials were not specifically targeted. Receives: Device: Ablation |
| Control | No intervention | Patient who underwent ablation using similar technology and irrigated catheters guided by standard substrate mapping techniques. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of VT recurrence or death
Measured: 36 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start12 Oct 2014
- Primary completion16 Sep 2019 (estimated)
- Study completion1 Jan 2020 (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.
- 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
- Non-randomised
- Intervention model
- Single group
- Model description
- This prospective, multi-center controlled study enrolles patients with infarct-related VT refractory to anti-arrhythmic drugs. The outcome of the study group will be compared to historical control group of patients matched for age, LVEF and VT burden.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Cardiovascular Reseach and Innovation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004624
- Sponsor's protocol ID
- PhysioVT1
- Status last verified
- Jun 2019
- First submitted
- 28 Jun 2019
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologically Guided Ablation of Reentry-Vulnerable-Zones for the Treatment of Post-Infarction Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT04004624
- Acronym / sponsor ID
- PhysioVT1
- Conditions
- Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Center for Cardiovascular Reseach and InnovationIndustry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation
- Study start
- 12 Oct 2014 (actual)
- Primary completion
- 16 Sep 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 2 Jul 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.
The purpose of this study is to determine the efficacy of VT ablation guided by functional evaluation of the substrate to specifically target the reentry-vulnerable zones in patients with infarct-related VT.
Detailed description
Activation mapping of VT is the gold-standard method for description of the reentrant circuit and identification of its isthmus, however this is uncommonly accomplished due to hemodynamic non-tolerance and limited temporal and spatial resolution. Substrate mapping has been developed as an alternative method to identify the isthmus of post-infarction VT during sinus rhythm (SR). However, it has limited specificity to critical VT sites.
Fundamental work in animal models of healed infarction and humans has shown that the VT isthmus corresponds to locations characterized by marked activation slowing during SR. Furthermore, these locations serve as "anchors" for multiple VT morphologies and cycle lengths.
The hypothesis of this study is that activation mapping during SR or pacing can improve the specifically for identifying the critical VT sites.
The aim of this prospective, multi-center controlled study is to evaluate the utility and limitations of functional mapping for guiding ablation of reentry vulnerably zones for long-term control of VT
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This prospective, multi-center controlled study enrolles patients with infarct-related VT refractory to anti-arrhythmic drugs. The outcome of the study group will be compared to historical control group of patients matched for age, LVEF and VT burden.
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Active comparator | Device: AblationThe left ventricle is mapped during atrial and right or left ventricular pacing (site close to the infarct) at a similar cycle length of 600ms. Radio-frequency ablation is performed selectively in areas of activation slowing (defined as ≤40ms per 5mm while voltage abnormalities and late potentials were not specifically targeted. |
| Control | No intervention | –Patient who underwent ablation using similar technology and irrigated catheters guided by standard substrate mapping techniques. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- History of myocardial infarction ≥1month before enrolment documented by ECG or cardiac imaging (TTE, SPECT, CMR).
- Planned for first VT ablation procedure.
- Patients must have an ICD or a plan for ICD implantation after the ablation.
- Ability to understand the requirement of the study and to sign an informed consent.
Key exclusion criteria (6 listed)
- Patients requiring long-term treatment with class I or class III antiarrhythmic drugs after ablation (for AF).
- The VT substrate is thought not to be related to coronary disease.
- Presence of ongoing ischemia that is thought to be the cause of the VT.
- Contraindication to anticoagulation therapy
- Stroke within 30 days before enrollment.
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 |
|---|---|---|
| AblationCardiac Ablation | Device | Study Arm |
Primary outcome
Composite of VT recurrence or death
Time frame: 36 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
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A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
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Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
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SPIKE FLOW Endocardial Lead Safety and Performance Study
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation in people with Ventricular Tachycardia, run by Center for Cardiovascular Reseach and Innovation.
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 5 inclusion and 6 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 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Composite of VT recurrence or death (time frame: 36 months follow-up). 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 2 Jul 2019.