Acute Study to Collect Electrical Signals From the Heart Using a Special Lead
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02772380|
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Tachycardia Ventricular Arrhythmias||Device: Defibrillation following induction of VT/VF||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Subjects who are undergoing a standard of care procedure will also undergo the ASD2 research procedure involving placing an investigational lead in the substernal space to gather electrograms during induced ventricular arrhythmias for future research/development.|
|Primary Purpose:||Device Feasibility|
|Official Title:||Acute Extravascular Defibrillation Study|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
Experimental: VT/ VF induction and defibrillation
Ventricular Tachycardia and Ventricular Fibrillation (VT/VF) induction and termination through use of a defibrillator, will be carried out as the intervention in all subjects undergoing study procedures.
Device: Defibrillation following induction of VT/VF
Up to 10 attempts to induce two VF/VT episodes for defibrillation testing
- Number of extravascular electrograms collected during ventricular fibrillation or ventricular tachycardia episodes [ Time Frame: Day of procedure ]Collect extravascular EGMs during induced VF/VT and intrinsic rhythms directly from an investigational lead placed in the extravascular space to be used for development of a future ICD.
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): NCT02772380