Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia (VT-CoA)
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|ClinicalTrials.gov Identifier: NCT00412607|
Recruitment Status : Completed
First Posted : December 18, 2006
Results First Posted : October 16, 2014
Last Update Posted : November 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Tachycardia||Device: NAVISTAR® THERMOCOOL® Catheter||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||249 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NaviStar ThermoCool Catheter for Endocardial RF Ablation in Patients With Ventricular Tachycardia|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
|Experimental: NaviStar ThermoCool Catheter||
Device: NAVISTAR® 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
- The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation. [ Time Frame: 12-month post ablation ]The long-term primary safety endpoint is 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. [ Time Frame: Seven days post 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.
- Percentage of Subjects Achieved Acute Success [ Time Frame: Duration from post-procedure to hospital discharge, up to 2 days ]Acute success was defined as the subjects receiving successful ablation of all targeted Ventricular Tachycardia (VT) and no recurrence prior to hospital discharge.
- Percentage of Subjects Who Achieved Chronic Effectiveness [ Time Frame: 6-month follow up ]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.
- Number of Subjects Achieved Long-term Efficacy Success [ Time Frame: 3-year follow up ]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.
- Change in Left Ventricular Ejection Fraction at 6 Month From Baseline [ Time Frame: 6-month follow up ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412607