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Ventricular TachycardiaPhase 4VT-CoANCT00412607

Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia

A Phase 4 study testing NAVISTAR® THERMOCOOL® Catheter in people with Ventricular Tachycardia, run by Biosense Webster, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective is to provide additional corroborative safety and efficacy data for the Navistar ThermoCool catheter for the treatment of subjects with ischemic Ventricular Tachycardia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ventricular Tachycardia
What is being tested?
NAVISTAR® THERMOCOOL® Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
249 participants
Where
No sites listed yet
Study dates
Jan 2007to Jun 2012
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented spontaneous episodes of sustained ventricular tachycardia (must satisfy one)
  • For patients with ICDs: Documented episodes must be four (4) or greater for entry into the study.
  • For patients without ICDs: Documented episodes must be two (2) or greater within two (2) months and the assessment will be performed by a review of ECGs and hospitalization records.
  • Incessant VT due to prior myocardial infarction (defined as present for more than one (1) hour and refractory to or immediately recurrent after administration of antiarrhythmic medication and cardioversion).
  • Spontaneous occurrence of symptomatic ventricular tachycardia despite antiarrhythmic drug therapy or ICD intervention.
  • Left ventricular ejection fraction > 10% as estimated by echocardiography, contrast ventriculography or radionuclide imaging within the previous ninety (90) days.
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  • Age eighteen (18) years or older.
  • Signed Patient Informed consent form.
  • Able and willing to comply with all pre-, post-, and follow-up testing requirements.

Who cannot join

  • Definite protruding left ventricular thrombus on pre-ablation echocardiogram.
  • Myocardial infarction within the preceding two (2) months. Patients with incessant VT (defined as present for more than one (1) hour and refractory to or immediately recurrent after administration of antiarrhythmic medication and cardioversion) may be enrolled if their MI is at least three (3) weeks old.
  • Patients with idiopathic VT.
  • Other disease process likely to limit survival to less than twelve (12) months.
  • Class IV heart failure.
  • Serum creatinine of > 2.5 mg/dl.
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  • Thrombocytopenia (defined as platelet count <80,000) or coagulopathy.
  • Contraindication to heparin.
  • Women who are pregnant.
  • Cardiac surgery (i.e. ventriculotomy, atriotomy) within the past two (2) months. Patients with incessant VT (present 50% of the time with intervention for a period >12 h) may be enrolled if their surgery is at least three (3) weeks old.
  • Acute illness or active systemic infection.
  • Unstable angina.
  • Severe aortic stenosis or flail mitral valve.
  • Uncontrolled heart failure.
  • Significant congenital anomaly or medical problem that, in the opinion of the Principal Investigator, would preclude enrollment in the study.
  • Enrolled in an investigational study evaluating another device or drug.

About this study

Official title: NaviStar ThermoCool Catheter for Endocardial RF Ablation in Patients With Ventricular Tachycardia

The primary objective is to provide additional corroborative safety and efficacy data for the Navistar ThermoCool catheter for the treatment of subjects with ischemic Ventricular Tachycardia.

Read the detailed description

This study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. The device is currently FDA approved for commercial distribution. Subjects with ischemic ventricular tachycardia will be considered for the condition of approval study. This study will be conducted at up to 30 centers in a minimum of 249 evaluable subjects.

Being tested
NAVISTAR® THERMOCOOL® Catheter
Keywords
Ventricular Tachycardia, Heart Diseases, Arrhythmia
Medical subject headings
Tachycardia, Ventricular, Heart Diseases, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NAVISTAR® THERMOCOOL® CatheterDevice

    The primary objective is to provide additional, corroborative safety data for the NAVISTAR THERMOCOOL catheter for the treatment of subjects with sustained, monomorphic VT or incessant VT associated with coronary artery disease

Study groups in NCT00412607
Study groupRoleWhat they receive
NaviStar ThermoCool CatheterExperimentalNot described
Receives: Device: NAVISTAR® THERMOCOOL® Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation.

    The long-term primary safety endpoint is the percentage of subjects that expire from all-cause mortality within 12-months post ablation.

    Measured: 12-month post ablation

  2. The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure.

    The acute primary safety endpoint is the percentage of subjects who experienced cardiovascular-specific adverse events (CSAE) within seven days of the ablation procedure.

    Measured: Seven days post ablation procedure

Secondary outcomes (4)

  1. Percentage of Subjects Achieved Acute Success

    Acute success was defined as the subjects receiving successful ablation of all targeted Ventricular Tachycardia (VT) and no recurrence prior to hospital discharge.

    Measured: Duration from post-procedure to hospital discharge, up to 2 days

  2. Percentage of Subjects Who Achieved Chronic Effectiveness

    Chronic effectiveness is defined as subjects without recurrence of sustained monomorphic ventricular tachycardia (SMVT) at 6 month follow-up. For subjects with Implantable Cardioverter Defibrillator (ICD), recurrences of SMVT were defined as appropriate ICD shock therapies. For subjects without ICDs, recurrences of SMVT were recorded in the follow-up visits form. Besides SMVT, recurrence of incessant VT was also captured in this study. Recurrence of incessant VT was recorded up to 6 month post ablation procedure but not beyond.

    Measured: 6-month follow up

  3. Number of Subjects Achieved Long-term Efficacy Success

    Long-term success is defined as patient-reported non-recurrence of Ventricular Tachycardia (VT) at the12-month, second year, and third year phone follow-ups.

    Measured: 3-year follow up

  4. Change in Left Ventricular Ejection Fraction at 6 Month From Baseline

    Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 6 month follow up. LVEF is a measure of the percentage of blood leaving heart each time it contracts. Baseline LVEF data were collected at pre ablation procedure, at hospital discharge, and at the 6-month follow-up visit.

    Measured: 6-month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionJun 2012
  4. Study completionJun 2012

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
249 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00412607
Sponsor's protocol ID
BWI40036
Acronym
VT-CoA
Status last verified
Jan 2025
First submitted
14 Dec 2006
Last updated
4 Feb 2025

Publications

  • Marchlinski FE, Haffajee CI, Beshai JF, Dickfeld TL, Gonzalez MD, Hsia HH, Schuger CD, Beckman KJ, Bogun FM, Pollak SJ, Bhandari AK. Long-Term Success of Irrigated Radiofrequency Catheter Ablation of Sustained Ventricular Tachycardia: Post-Approval THERMOCOOL VT Trial. J Am Coll Cardiol. 2016 Feb 16;67(6):674-683. doi: 10.1016/j.jacc.2015.11.041.

    PubMed 26868693

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing NAVISTAR® THERMOCOOL® Catheter in people with Ventricular Tachycardia, run by Biosense Webster, Inc..

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 9 inclusion and 16 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 4 Feb 2025. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2014). 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?

The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation. (time frame: 12-month post ablation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00412607, which also lists 1 linked publication.

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 4 Feb 2025.

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