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CompletedNCT00412607VT-CoAUpdated Feb 4, 2025Results posted

Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia

A Phase 4 interventional study of NAVISTAR® THERMOCOOL® Catheter in Ventricular Tachycardia, sponsored by Biosense Webster, Inc.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.

Sponsored by Biosense Webster, Inc. (part of Johnson & Johnson) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
249
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Ventricular Tachycardia

Keywords

  • Ventricular Tachycardia
  • Heart Diseases
  • Arrhythmia
03

In context

Tachycardia, Ventricular

443 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.

This study's enrollment of 249 is above the median of 64 across 269 interventional studies indexed under Tachycardia, Ventricular.

Browse Tachycardia, Ventricular studies →

Lead sponsor

Biosense Webster, Inc. is the lead sponsor of 64 studies on the registry; 10 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 24 (92%) have results posted.

Browse Biosense Webster, Inc. studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Documented spontaneous episodes of sustained ventricular tachycardia (must satisfy one)

    1. For patients with ICDs: Documented episodes must be four (4) or greater for entry into the study.
    2. 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.
    3. 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).
  2. Spontaneous occurrence of symptomatic ventricular tachycardia despite antiarrhythmic drug therapy or ICD intervention.
  3. Left ventricular ejection fraction > 10% as estimated by echocardiography, contrast ventriculography or radionuclide imaging within the previous ninety (90) days.
  4. Age eighteen (18) years or older.
  5. Signed Patient Informed consent form.
  6. Able and willing to comply with all pre-, post-, and follow-up testing requirements.

Exclusion criteria

Exclusion Criteria:

  1. Definite protruding left ventricular thrombus on pre-ablation echocardiogram.
  2. 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.
  3. Patients with idiopathic VT.
  4. Other disease process likely to limit survival to less than twelve (12) months.
  5. Class IV heart failure.
  6. Serum creatinine of > 2.5 mg/dl.
  7. Thrombocytopenia (defined as platelet count \<80,000) or coagulopathy.
  8. Contraindication to heparin.
  9. Women who are pregnant.
  10. 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.
  11. Acute illness or active systemic infection.
  12. Unstable angina.
  13. Severe aortic stenosis or flail mitral valve.
  14. Uncontrolled heart failure.
  15. Significant congenital anomaly or medical problem that, in the opinion of the Principal Investigator, would preclude enrollment in the study.
  16. Enrolled in an investigational study evaluating another device or drug.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
249 participants (actual)

Study arms

  • Experimental
    NaviStar ThermoCool Catheter

    Device: NAVISTAR® THERMOCOOL® Catheter

Interventions

  • DeviceNAVISTAR® THERMOCOOL® Catheter

    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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: Seven days post ablation procedure

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 6-month follow up

07

Results

Posted Oct 16, 2014

Participant flow

The first subject was enrolled on April 3, 2007. Subject enrollment was completed on May 19, 2009 after reaching the minimum enrollment criteria of two hundred forty-nine (249) subjects. Subject follow-up was completed on June 8, 2012.

Participant flow — Overall Study
MilestoneNAVISTAR THERMOCOOL Catheter
Started249
Started study catheter233
Completed145
Not completed104
Withdrew: Withdrawal by subject9
Withdrew: Lost to follow-up19
Withdrew: Death61
Withdrew: Not meet inclusion/exclusion criteria15

Outcome measures

PrimaryThe 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.

Time frame:
12-month post ablation
Reported as:
Number · percentage of mortality
The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation.
percentage of mortalityNAVISTAR THERMOCOOL Catheter
The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation.13.3 (0 to 17.5)
Statistical analysis
  • NAVISTAR THERMOCOOL Catheter · Fisher Exact · Percentage of mortality: 13.3The 95% confidence interval is a one-sided with upper confidence level = 17.5% computed using the exact binomial test.
SecondaryPercentage 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.

Time frame:
Duration from post-procedure to hospital discharge, up to 2 days
Reported as:
Number · Percentage of participants
Percentage of Subjects Achieved Acute Success
Percentage of participantsNAVISTAR THERMOCOOL Catheter
Percentage of Subjects Achieved Acute Success74.9
PrimaryThe 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.

Time frame:
Seven days post ablation procedure
Reported as:
Number · percentage of Adverse Event
The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure.
percentage of Adverse EventNAVISTAR THERMOCOOL Catheter
The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure.4.3 (0 to 7.2)
SecondaryPercentage 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.

Time frame:
6-month follow up
Reported as:
Number · Percentage of participants
Percentage of Subjects Who Achieved Chronic Effectiveness
Percentage of participantsNAVISTAR THERMOCOOL Catheter
Percentage of Subjects Who Achieved Chronic Effectiveness62.0
SecondaryNumber 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.

Time frame:
3-year follow up
Reported as:
Number · participants
Number of Subjects Achieved Long-term Efficacy Success
participantsTotalReported RecurrenceReported No Recurrence
12-Month Follow-up17640136
2-Year Follow-up16148113
3-Year Follow-up14134107
SecondaryChange 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.

Time frame:
6-month follow up
Reported as:
Mean · percentage of blood leaving the heart
Change in Left Ventricular Ejection Fraction at 6 Month From Baseline
percentage of blood leaving the heartNAVISTAR THERMOCOOL Catheter
Baseline (Pre-Ablation)30.6 ± 12.5
6-Month32.9 ± 11.53
Change from Baseline0.9 ± 8.23

Adverse events

Collected over 3-year follow up. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NAVISTAR THERMOCOOL Catheter—37/233 (15.9%)177/233 (76%)
Most frequent serious events
Showing 10 of 25
Most frequent serious events
EventNAVISTAR THERMOCOOL Catheter
Ventricular TachycardiaCardiac disorders8/233
Congestive Heart FailureCardiac disorders5/233
Urinary Tract Infection/Urinary Retention RetentionInfections and infestations5/233
DeathCardiac disorders3/233
Pericardial EffusionCardiac disorders3/233
Renal FailureRespiratory, thoracic and mediastinal disorders3/233
MRSAInfections and infestations2/233
PseudoaneurysmInjury, poisoning and procedural complications2/233
BradycardiaCardiac disorders1/233
PalpitationsCardiac disorders1/233
Most frequent other events
Showing 10 of 97
Most frequent other events
EventNAVISTAR THERMOCOOL Catheter
Ventricular TachycardiaCardiac disorders68/233
Congestive Heart FailureCardiac disorders50/233
Atrial fibrillationCardiac disorders22/233
DeathInvestigations12/233
Implantable Cardioverter Defibrillator maintenanceCardiac disorders10/233
Implantable Cardioverter Defibrillator shock - Not Elsewhere ClassifiedCardiac disorders10/233
HematomaInjury, poisoning and procedural complications9/233
PneumoniaInfections and infestations8/233
SepsisInfections and infestations7/233
Angina pectorisCardiac disorders6/233

Baseline characteristics

All enrolled subjects who signed the informed consent form and were eligible for inclusion in the clinical study

Age, Continuous
Age, Continuous(years)NAVISTAR THERMOCOOL Catheter
Mean67.4 ± 9.8
Sex: Female, Male
Sex: Female, Male(Participants)NAVISTAR THERMOCOOL Catheter
Female15
Male234
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)NAVISTAR THERMOCOOL Catheter
Asian0
Black14
Caucasian229
Hispanic4
Other2
Region of Enrollment
Region of Enrollment(participants)NAVISTAR THERMOCOOL Catheter
United States249
08

Study locations

No study locations are listed for this record.

09

References and documents

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 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2007, a primary completion of Jun 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.

Results were first posted in Oct 2014, 2 years 4 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 14, 2006
First posted
Dec 18, 2006
Start
Jan 2007
Primary completionActual
Jun 2012
CompletionActual
Jun 2012
Results first posted
Oct 16, 2014
Last update
Feb 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00412607
Lead sponsor
Biosense Webster, Inc.
Responsible party
Sponsor
First posted
Dec 18, 2006
Start date
Jan 2007
Primary completion
Jun 2012
Completion
Jun 2012
Results posted
Oct 16, 2014
Last update
Feb 4, 2025
View the source record on ClinicalTrials.gov ↗

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