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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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

Other trials in United States

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.

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 groups in NCT00721032
Study groupRoleWhat they receive
1ExperimentalMagnetic resonance imaging (MRI)-guided ablation of ventricular tachycardia.
Receives: Procedure: MRI guided VT ablation
2Active comparatorAnti-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.

  1. Freedom from ventricular tachycardia documented by implantable defibrillator cardioverter 6 months post ablation.

    Measured: 6 months

Secondary outcomes (4)
  1. inducible arrhythmia at the end of the procedure,

    Measured: During procedure

  2. Procedure time

    Measured: During procedure

  3. Comparison of endocardial voltage mapping to scar on delayed enhancement MRI images

    Measured: During procedure

  4. 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.

  1. First posted23 Jul 2008 (estimated)
  2. Study startJun 2012
  3. Primary completionAug 2015 (estimated)
  4. Study completionAug 2015 (estimated)

Why it stopped: PI left the institution

Resources

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)
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

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.

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