Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia
The purpose of the study is to assess the effectiveness and safety of a new device called an Intramural Needle Ablation Catheter (INA catheter). The INA catheter is used for locating and ablating ventricular arrhythmias that have failed standard radiofrequency ablation. This approach is desirable because some people have ventricular arrhythmias that originate deep within the heart muscle where it is not abolished by ablation with standard catheters.
The investigators seek to determine whether the INA catheter can potentially help people who have ventricular arrhythmias that have failed standard radiofrequency ablation. The investigators also want to determine if it is likely to be safe, without excessive side effects.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Early Feasibility Study of Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation|
- Control of Ventricular Tachycardia (VT) [ Time Frame: 6 months ]Freedom from hospitalization for recurrent Ventricular Tachycardia during the 6 months following ablation.
- Absence of all serious adverse events [ Time Frame: 30 days ]Absence of serious adverse events that are potentially device related and occur within 30 days of the ablation procedure
- Reduction of ventricular arrhythmia causing significant ventricular dysfunction [ Time Frame: 6 months ]decrease in ambient ventricular arrhythmia to < 5000 ventricular beats daily
- Acute Procedural Success [ Time Frame: Absence of inducible clinical VT at then end of the ablation procedure. ]Defined as termination of at least one clinical or presumptive clinical monomorphic VT by Radiofrequency ablation and/or rendering that VT no longer inducible. It is recognized that this secondary efficacy endpoint will not be assessed in all patients because VT induction will not be attempted in patients in whom, in the judgment of the investigator, attempted VT induction imposes unwarranted risk of hemodynamic deterioration. A clinical or presumptive clinical VT is one that has been documented to occur spontaneously, or is within 20 ms in cycle length of a VT that has been documented to occur spontaneously.
|Study Start Date:||September 2016|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
Experimental: Intramural Needle Catheter Ablation
Ablation of Ventricular Tachycardia with Intramural Needle Ablation Catheter
|Device: Intramural Needle Ablation Catheter|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01791543
|Contact: Christine P. Pellegrini, MSN/MHSAfirstname.lastname@example.org|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Sub-Investigator: William G. Stevenson, M.D.|
|Principal Investigator: Usha Tedrow, M.D.|
|Study Director:||William G. Stevenson, M.D.||Brigham and Women's Hospital|
|Principal Investigator:||Usha Tedrow, M.D.||Brigham and Women's Hospital|