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Catheter Ablation

Catheter Evaluation for Endocardial Ablation in Patients With 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
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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%
Chest Pain - Non cardiac
3%
Sepsis
3%
Arrhythmia - Not Elsewhere Classified
3%
Hypokalemia
3%
Pneumonia
3%
Cardiac - Not Elsewhere Classified
3%
Coronary Artery Disease
3%
Angina pectoris
2%
Renal Failure
2%
Atrial Tachycardia
2%
Cardiac stents
2%
Myocardial Infarction
2%
Thrombus
2%
Urinary Tract Infection/Urinary Retention Retention
2%
Chronic obstructive pulmonary disease
2%
Hypotension
1%
Infection - Not Elsewhere Classified
1%
Fluid overload
1%
Heart Transplant
1%
MRSA
1%
Gastrointestinal bleed
1%
Chest Pain - Not Elsewhere Classified
1%
Weakness
1%
Bronchitis
1%
Fever
1%
Cardiac Arrest
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

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
126 Previous Clinical Trials
36,802 Total Patients Enrolled
~13 spots leftby Jan 2026
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