Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01791543|
Recruitment Status : Recruiting
First Posted : February 15, 2013
Last Update Posted : July 9, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Tachycardia||Device: Intramural Needle Ablation Catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Feasibility Study of Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation|
|Actual Study Start Date :||September 2016|
|Estimated Primary Completion Date :||January 27, 2021|
|Estimated Study Completion Date :||May 27, 2021|
Experimental: Intramural Needle Catheter Ablation
Ablation of Ventricular Tachycardia with Intramural Needle Ablation Catheter
Device: Intramural Needle Ablation Catheter
- 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.
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): NCT01791543
|Contact: Sherry Bowman, MSN/MHSAfirstname.lastname@example.org|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Usha Tedrow, M.D. 857-307-1947 email@example.com|
|Principal Investigator: Usha Tedrow, M.D.|
|United States, Tennessee|
|Vanderbilt Heart and Vascular Institute||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: William G Stevenson, M.D. 615-936-7537 firstname.lastname@example.org|
|Principal Investigator: William G Stevenson, M.D.|
|Study Director:||William G. Stevenson, M.D.||Vanderbilt Heart and Vascular Institute|
|Principal Investigator:||Usha Tedrow, M.D.||Brigham and Women's Hospital|