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Catheter Ablation

NaviStar ThermoCool Catheter for Ventricular Tachycardia (VT-CoA Trial)

Phase 4
Waitlist Available
Research Sponsored by Biosense Webster, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-year follow up
Awards & highlights

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.

Eligible Conditions
  • Ventricular Tachycardia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-year follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-year follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation.
The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure.
Secondary outcome measures
Change in Left Ventricular Ejection Fraction at 6 Month From Baseline
Number of Subjects Achieved Long-term Efficacy Success
Percentage of Subjects Achieved Acute Success
+1 more

Side effects data

From 2012 Phase 4 trial • 249 Patients • NCT00412607
29%
Ventricular Tachycardia
21%
Congestive Heart Failure
9%
Atrial fibrillation
5%
Death
4%
Hematoma
4%
Implantable Cardioverter Defibrillator maintenance
4%
Implantable Cardioverter Defibrillator shock - Not Elsewhere Classified
3%
Arrhythmia - Not Elsewhere Classified
3%
Chest Pain - Non cardiac
3%
Sepsis
3%
Hypokalemia
3%
Pneumonia
3%
Cardiac - Not Elsewhere Classified
3%
Coronary Artery Disease
3%
Angina pectoris
2%
Atrial Tachycardia
2%
Cardiac stents
2%
Renal Failure
2%
Myocardial Infarction
2%
Thrombus
2%
Urinary Tract Infection/Urinary Retention Retention
2%
Chronic obstructive pulmonary disease
2%
Hypotension
1%
MRSA
1%
Chest Pain - Not Elsewhere Classified
1%
Weakness
1%
Bronchitis
1%
Fever
1%
Cardiac Arrest
1%
Heart Transplant
1%
Gastrointestinal bleed
1%
Fluid overload
1%
Infection - Not Elsewhere Classified
1%
Lung cancer
1%
Pseudoaneurysm
1%
Mitral valve regurgitation
1%
Pericardial effusion
1%
Pleural Effusion
1%
Viral infection
1%
Heart Block
1%
Epitaxis
1%
Aortic Aneurysm
1%
Hypertension
1%
Pericardial Effusion
1%
Stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
NAVISTAR THERMOCOOL Catheter

Trial Design

1Treatment groups
Experimental Treatment
Group I: NaviStar ThermoCool CatheterExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NAVISTAR® THERMOCOOL® Catheter
2004
Completed Phase 4
~420

Find a Location

Who is running the clinical trial?

Biosense Webster, Inc.Lead Sponsor
123 Previous Clinical Trials
36,368 Total Patients Enrolled
~13 spots leftby Sep 2025
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