Ventricular TachycardiaNCT00721032
Anti-arrhythmic Medication v. MRI-Merge Ablation in the Treatment of Ventricular Tachycardia
A study testing MRI guided VT ablation and Increased dose of amiodarone in people with Ventricular Tachycardia, run by Johns Hopkins University at 1 site in United States.
Trial summary
Ventricular tachycardia (VT) is a morbid arrhythmia responsible for many sudden deaths and ICD shocks. Despite much progress in the treatment of arrhythmia, VT remains a therapeutic challenge. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- MRI guided VT ablation and Increased dose of amiodarone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Aug 2015
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current treatment with amiodarone
- Ischemic or non-ischemic cardiomyopathy
- Monomorphic ventricular tachycardia at any cycle length, with > 1 occurrence of the same cycle length and morphology, at least one episode needs to be of sufficient duration to result in a shock.
- No contraindication to up titration of meds or to VT radiofrequency ablation (RFA)
Who cannot join
- Primary antiarrhythmic medication other than amiodarone
- Amiodarone at dose of 600 mg daily or higher
- Polymorphic VT as culprit rhythm
- History of metal exposure (welding)
- Pregnant women
- Recent myocardial infarction
Show all 9Show fewer
- Planned coronary revascularization
- Implantable cardiac devices not previously tested for safety in the setting of MRI
- Glomerular Filtration Rate (GFR) < 30 ml/min
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Ventricular tachycardia (VT) is a morbid arrhythmia responsible for many sudden deaths and ICD shocks. Despite much progress in the treatment of arrhythmia, VT remains a therapeutic challenge. Most patients with VT have an implantable cardioverter defibrillator (ICD) for secondary prevention of sudden cardiac death, however, an ICD merely treats VT, it does not prevent VT. In patients with recurrent VT and ICD shocks, two strategies are available to decrease the burden of VT. The first is antiarrhythmic drugs, and the second is VT ablation. The aim of this study is to compare the efficacy of antiarrhythmic drugs and VT ablation guided by MRI. VT can sometimes be suppressed with antiarrhythmic medications, however, these are often ineffective, and carry a high burden of side effects. Many forms of VT can be cured by selective destruction of critical electrical pathways with catheter ablation. A major limitation in the ablation of VT, however, is the time required to localize scar tissue and important pathways for targeting of lesions. Magnetic resonance imaging can now obtain reliable images of scar location within the ventricles. Recent advances in electroanatomical mapping systems allow operators to import pre-acquired images into the mapping system. The aim of this study is to examine the feasibility of importing historic MRI scar maps of the ventricles into the electroanatomical system and using such images to guide catheter ablation, as compared to antiarrhythmic drug suppression of VT. We suspect that MRI guidance will be especially useful in patients with "unstable" VT, i.e. VT that causes an abrupt drop in blood pressure, and thus cannot be maintained in the electrophysiology (EP) lab for mapping and entertainment purposes. Patients referred for VT ablation have ICDs. Through previously completed animal work (Circulation 2004; 110(5): 475-82) and a human trial (2006 Sep 19;114(12):1277-84) we have demonstrated the safety of MRI in the setting of pacemakers and implantable defibrillators using appropriate precautions. Through careful device programming and using MRI sequences with limited energy exposure (specific absorption rate < 2 W/kg) we will study the pre procedural myocardial anatomy of patients enrolled into this study.
The primary endpoint will be lack of VT documented by implantable defibrillator (when present) interrogation or Holter monitoring 6 months post ablation. The secondary endpoints will be comparison of inducible arrhythmia at the end of the procedure, procedure time, comparison of endocardial voltage mapping to scar on delayed enhancement MRI images, and complications in each study arm.
- Conditions
- Ventricular Tachycardia
- Being tested
- MRI guided VT ablation, Increased dose of amiodarone
- Keywords
- Ventricular tachycardia (VT), Implantable cardioverter-defibrillator (ICD), Ablation, Cardiomyopathy, Electrophysiology study
- Medical subject headings
- Tachycardia, Ventricular, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI guided VT ablationProcedure or surgery
Magnetic resonance imaging (MRI)-guided ablation of ventricular tachycardia (VT)
Increased dose of amiodaroneDrug
Increase the dose of amiodarone according to the following scheme:
current dose -> new dose 100 once daily (QD) -> 200 QD; 200 QD -> 400 QD; 300 QD -> 600 QD; 400 QD -> 600 QD
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Magnetic resonance imaging (MRI)-guided ablation of ventricular tachycardia. Receives: Procedure: MRI guided VT ablation |
| 2 | Active comparator | Anti-arrhythmic group. Receives: Drug: Increased dose of amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from ventricular tachycardia documented by implantable defibrillator cardioverter 6 months post ablation.
Measured: 6 months
Secondary outcomes (4)
inducible arrhythmia at the end of the procedure,
Measured: During procedure
Procedure time
Measured: During procedure
Comparison of endocardial voltage mapping to scar on delayed enhancement MRI images
Measured: During procedure
Complications of the procedure
Measured: 30 days following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startJun 2012
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Why it stopped: PI left the institution
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.
- More trials run by Johns Hopkins 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721032
- Sponsor's protocol ID
- NA_00011012
- Status last verified
- May 2017
- First submitted
- 21 Jul 2008
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-arrhythmic Medication v. MRI-Merge Ablation in the Treatment of Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT00721032
- Acronym / sponsor ID
- NA_00011012
- Conditions
- Ventricular Tachycardia
- Keywords
- Ventricular tachycardia (VT), Implantable cardioverter-defibrillator (ICD), Ablation, Cardiomyopathy, Electrophysiology study
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 23 Jul 2008 (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.
Ventricular tachycardia (VT) is a morbid arrhythmia responsible for many sudden deaths and ICD shocks. Despite much progress in the treatment of arrhythmia, VT remains a therapeutic challenge. Most patients with VT have an implantable cardioverter defibrillator (ICD) for secondary prevention of sudden cardiac death, however, an ICD merely treats VT, it does not prevent VT. In patients with recurrent VT and ICD shocks, two strategies are available to decrease the burden of VT. The first is antiarrhythmic drugs, and the second is VT ablation. The aim of this study is to compare the efficacy of antiarrhythmic drugs and VT ablation guided by MRI. VT can sometimes be suppressed with antiarrhythmic medications, however, these are often ineffective, and carry a high burden of side effects. Many forms of VT can be cured by selective destruction of critical electrical pathways with catheter ablation. A major limitation in the ablation of VT, however, is the time required to localize scar tissue and important pathways for targeting of lesions. Magnetic resonance imaging can now obtain reliable images of scar location within the ventricles. Recent advances in electroanatomical mapping systems allow operators to import pre-acquired images into the mapping system. The aim of this study is to examine the feasibility of importing historic MRI scar maps of the ventricles into the electroanatomical system and using such images to guide catheter ablation, as compared to antiarrhythmic drug suppression of VT. We suspect that MRI guidance will be especially useful in patients with "unstable" VT, i.e. VT that causes an abrupt drop in blood pressure, and thus cannot be maintained in the electrophysiology (EP) lab for mapping and entertainment purposes. Patients referred for VT ablation have ICDs. Through previously completed animal work (Circulation 2004; 110(5): 475-82) and a human trial (2006 Sep 19;114(12):1277-84) we have demonstrated the safety of MRI in the setting of pacemakers and implantable defibrillators using appropriate precautions. Through careful device programming and using MRI sequences with limited energy exposure (specific absorption rate < 2 W/kg) we will study the pre procedural myocardial anatomy of patients enrolled into this study.
The primary endpoint will be lack of VT documented by implantable defibrillator (when present) interrogation or Holter monitoring 6 months post ablation. The secondary endpoints will be comparison of inducible arrhythmia at the end of the procedure, procedure time, comparison of endocardial voltage mapping to scar on delayed enhancement MRI images, and complications in each study arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: MRI guided VT ablationMagnetic resonance imaging (MRI)-guided ablation of ventricular tachycardia. |
| 2 | Active comparator | Drug: Increased dose of amiodaroneAnti-arrhythmic group. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current treatment with amiodarone
- Ischemic or non-ischemic cardiomyopathy
- Monomorphic ventricular tachycardia at any cycle length, with > 1 occurrence of the same cycle length and morphology, at least one episode needs to be of sufficient duration to result in a shock.
- No contraindication to up titration of meds or to VT radiofrequency ablation (RFA)
Key exclusion criteria (9 listed)
- Primary antiarrhythmic medication other than amiodarone
- Amiodarone at dose of 600 mg daily or higher
- Polymorphic VT as culprit rhythm
- History of metal exposure (welding)
- Pregnant women
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 |
|---|---|---|
| MRI guided VT ablationMagnetic resonance imaging (MRI)-guided ablation of ventricular tachycardia (VT) | Procedure or surgery | 1 |
| Increased dose of amiodaroneIncrease the dose of amiodarone according to the following scheme: current dose -> new dose 100 once daily (QD) -> 200 QD; 200 QD -> 400 QD; 300 QD -> 600 QD; 400 QD -> 600 QD | Drug | 2 |
Primary outcome
Freedom from ventricular tachycardia documented by implantable defibrillator cardioverter 6 months post ablation.
Time frame: 6 months
4 secondary outcomes
inducible arrhythmia at the end of the procedure,
Time frame: During procedure
Procedure time
Time frame: During procedure
Comparison of endocardial voltage mapping to scar on delayed enhancement MRI images
Time frame: During procedure
Complications of the procedure
Time frame: 30 days following procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI guided VT ablation and Increased dose of amiodarone in people with Ventricular Tachycardia, run by Johns Hopkins University 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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 10 May 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Freedom from ventricular tachycardia documented by implantable defibrillator cardioverter 6 months post ablation. (time frame: 6 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 May 2017.