Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia

NCT00412607 | Completed Phase 4 Results

• 1 other identifier: BWI40036
• Study Type: interventional
• Target: 249
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ventricular Tachycardia

Keywords

Ventricular Tachycardia; Heart Diseases; Arrhythmia

Outcome Measures

Primary Outcomes (2)

• 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.

  12-month post ablation

• 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.

  Seven days post ablation procedure

Secondary Outcomes (4)

• Percentage of Subjects Achieved Acute Success

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

• Percentage of Subjects Who Achieved Chronic Effectiveness

  6-month follow up

• Number of Subjects Achieved Long-term Efficacy Success

  3-year follow up

• Change in Left Ventricular Ejection Fraction at 6 Month From Baseline

  6-month follow up

Study Arms (1)

NaviStar ThermoCool Catheter

EXPERIMENTAL

Device: NAVISTAR® THERMOCOOL® Catheter

Interventions

NAVISTAR® THERMOCOOL® Catheter DEVICE

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

NaviStar ThermoCool Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Related Publications (1)

• 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.

  PMID: 26868693 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular; Heart Diseases; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Tachycardia; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Karen Cropper, Manager, Clinical Operations
• Organization: Biosense Webster, Inc.

Kcropper@its.jnj.com

(800) 729-9010

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2006
• First Posted: December 18, 2006
• Study Start: January 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 4, 2025
• Results First Posted: October 16, 2014

Record last verified: 2025-01