Ventricular TachycardiaNCT03212326
Contrast ICE for Myocardial Scar in VT Ablations
A study testing Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY] in people with Ventricular Tachycardia and Ischemic Cardiomyopathy, run by Weill Medical College of Cornell University.
Trial summary
There is a high correlation between scar areas identified by contrast-enhanced ICE and scar areas identified by conventional electroanatomic mapping. Therefore, the investigators will assess the utility of contrast-enhanced ICE to identify and localize myocardial scar real-time during VT ablation procedures. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ventricular Tachycardia, Ischemic Cardiomyopathy
- What is being tested?
- Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 years of age or older
- Subject is undergoing catheter ablation of likely reentrant VT
- Planned use of intracardiac echocardiography (ICE)
- Subject is willing to sign and date the study informed consent form
Who cannot join
- Contraindication to Perflutren (Optison) echo contrast
- Known right-to-left, bidirectional, or transient right-to-left cardiac shunts
- Known hypersensitivity to Perflutren, blood, blood products or albumin
- Subject has medical condition that would limit study participation (as per MD discretion)
- Subject is pregnant
- Inability to give informed consent
About this study
Official title: Contrast Enhanced Intracardiac Echocardiography (ICE) for Localization of Myocardial Scar During Ablation of Ventricular Tachycardia
There is a high correlation between scar areas identified by contrast-enhanced ICE and scar areas identified by conventional electroanatomic mapping. Therefore, the investigators will assess the utility of contrast-enhanced ICE to identify and localize myocardial scar real-time during VT ablation procedures.
Read the detailed description
Ventricular tachycardia (VT) is a life-threatening arrhythmia which occurs frequently in the setting of structural heart disease, most often as result of myocardial fibrosis or scar. Catheter ablation is often performed to treat recurrent VT, but is predicated on precise localization of myocardial scar, as scar is often the source of VT. Currently during VT ablation procedures the identification of scar is based on electroanatomic mapping where bipolar voltage criteria have been established (i.e., bipolar electrogram voltage < 1.5 mV is considered scar). However this definition is purely based on electrical signal information and so has significant limitations: 1) there has not been definitive establishment of the sensitivity and specificity of this threshold for defining scar in comparison with tissue; 2) a detailed 3-D map created by time-consuming movement of the mapping catheter must be obtained in order to assess the existence and location of the scar; 3) only scar on the surface in contact with the mapping catheter (most often endocardial) may be definitively identified, whereas there may be intramyocardial or epicardial scar that would not be identified unless the mapping catheter makes direct contact with those areas which may involve additional risky access (epicardial) or even impossible (intramyocardial). For these reasons it would be very helpful to have another method to identify and localize myocardial scar during a VT ablation procedure. Cardiac MRI has been validated for identifying and localizing scar, but would not be recommended for many patients due to presence of ICD (implantable cardioverter-defibrillator) devices in these patients. Contrast-enhanced echocardiography has been validated to identify myocardial scar (Montant 2010), and intracardiac echocardiography (ICE) is standardly used in VT ablation procedures. Therefore, the investigators will assess the utility of contrast enhanced ICE by identifying and localizing myocardial scar real-time during VT ablation procedures.
- Conditions
- Ventricular Tachycardia, Ischemic Cardiomyopathy
- Being tested
- Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]Drug
Perflutren 1.3mL diluted in 50 mL is infused intravenously, and intracardiac echo imaging is recorded to analyze for areas of possible myocardial scar, which is then compared with areas of abnormal electrical signal via direct catheter mapping which is performed during ablation of ventricular tachycardia.
| Study group | Role | What they receive |
|---|---|---|
| Definity | Experimental | Perflutren echo contrast is infused to enhance intracardiac echo imaging recorded during catheter ablation of ventricular tachycardia. We will compare areas that appear to be myocardial scar on ultrasound with areas of abnormal electrical signals obtained by direct catheter mapping. Receives: Drug: Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Myocardial Scar on Echo and Voltage Maps
location of left ventricular myocardial scar and abnormal electrograms
Measured: day 0 (intraoperative: data collected during the mapping procedure)
Secondary outcomes (1)
Number of Subjects With Ventricular Tachycardia Mapped
If ventricular tachycardia was induced and mapped then this counts as yes
Measured: day 0 (intraoperative: data collected during the mapping procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startMar 2013
- Primary completionSep 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor
- Investigators
- Christopher Liu, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212326
- Sponsor's protocol ID
- 1205012398
- Status last verified
- May 2019
- First submitted
- 6 Jul 2017
- Last updated
- 12 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Intracardiac Echocardiography (ICE) for Localization of Myocardial Scar During Ablation of Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT03212326
- Acronym / sponsor ID
- 1205012398
- Conditions
- Ventricular Tachycardia, Ischemic Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- Mar 2013 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Posted 31 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a high correlation between scar areas identified by contrast-enhanced ICE and scar areas identified by conventional electroanatomic mapping. Therefore, the investigators will assess the utility of contrast-enhanced ICE to identify and localize myocardial scar real-time during VT ablation procedures.
Detailed description
Ventricular tachycardia (VT) is a life-threatening arrhythmia which occurs frequently in the setting of structural heart disease, most often as result of myocardial fibrosis or scar. Catheter ablation is often performed to treat recurrent VT, but is predicated on precise localization of myocardial scar, as scar is often the source of VT. Currently during VT ablation procedures the identification of scar is based on electroanatomic mapping where bipolar voltage criteria have been established (i.e., bipolar electrogram voltage < 1.5 mV is considered scar). However this definition is purely based on electrical signal information and so has significant limitations: 1) there has not been definitive establishment of the sensitivity and specificity of this threshold for defining scar in comparison with tissue; 2) a detailed 3-D map created by time-consuming movement of the mapping catheter must be obtained in order to assess the existence and location of the scar; 3) only scar on the surface in contact with the mapping catheter (most often endocardial) may be definitively identified, whereas there may be intramyocardial or epicardial scar that would not be identified unless the mapping catheter makes direct contact with those areas which may involve additional risky access (epicardial) or even impossible (intramyocardial). For these reasons it would be very helpful to have another method to identify and localize myocardial scar during a VT ablation procedure. Cardiac MRI has been validated for identifying and localizing scar, but would not be recommended for many patients due to presence of ICD (implantable cardioverter-defibrillator) devices in these patients. Contrast-enhanced echocardiography has been validated to identify myocardial scar (Montant 2010), and intracardiac echocardiography (ICE) is standardly used in VT ablation procedures. Therefore, the investigators will assess the utility of contrast enhanced ICE by identifying and localizing myocardial scar real-time during VT ablation procedures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Definity | Experimental | Drug: Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]Perflutren echo contrast is infused to enhance intracardiac echo imaging recorded during catheter ablation of ventricular tachycardia. We will compare areas that appear to be myocardial scar on ultrasound with areas of abnormal electrical signals obtained by direct catheter mapping. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is 18 years of age or older
- Subject is undergoing catheter ablation of likely reentrant VT
- Planned use of intracardiac echocardiography (ICE)
- Subject is willing to sign and date the study informed consent form
Key exclusion criteria (6 listed)
- Contraindication to Perflutren (Optison) echo contrast
- Known right-to-left, bidirectional, or transient right-to-left cardiac shunts
- Known hypersensitivity to Perflutren, blood, blood products or albumin
- Subject has medical condition that would limit study participation (as per MD discretion)
- Subject is pregnant
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 |
|---|---|---|
| Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]Perflutren 1.3mL diluted in 50 mL is infused intravenously, and intracardiac echo imaging is recorded to analyze for areas of possible myocardial scar, which is then compared with areas of abnormal electrical signal via direct catheter mapping which is performed during ablation of ventricular tachycardia. | Drug | Definity |
Primary outcome
Number of Subjects With Myocardial Scar on Echo and Voltage Maps
Time frame: day 0 (intraoperative: data collected during the mapping procedure)
location of left ventricular myocardial scar and abnormal electrograms
1 secondary outcome
Number of Subjects With Ventricular Tachycardia Mapped
Time frame: day 0 (intraoperative: data collected during the mapping procedure)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
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.
Christopher Liu, MD principal investigator
Weill Medical College of Cornell University
Questions about this trial
What is this clinical trial studying?
A study testing Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY] in people with Ventricular Tachycardia and Ischemic Cardiomyopathy, run by Weill Medical College of Cornell University.
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 4 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: finished, as of the sponsor's last update on 12 Jun 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?
Yes. Results are posted in the registry (first posted 31 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With Myocardial Scar on Echo and Voltage Maps (time frame: day 0 (intraoperative: data collected during the mapping 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 12 Jun 2019.