Acute Study to Collect Electrical Signals From the Heart Using a Special Lead
Acute Extravascular Defibrillation Study
2 other identifiers
interventional
87
12 countries
36
Brief Summary
The main purpose of this clinical study is to collect electrograms from an investigational lead placed in an extravascular space, for development of a future Implantable Cardioverter Defibrillator (ICD) system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2016
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedFirst Posted
Study publicly available on registry
May 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedJune 19, 2018
March 1, 2018
1.3 years
April 27, 2016
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of extravascular electrograms collected during ventricular fibrillation or ventricular tachycardia episodes
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.
Day of procedure
Study Arms (1)
VT/ VF induction and defibrillation
EXPERIMENTALVentricular 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.
Interventions
Up to 10 attempts to induce two VF/VT episodes for defibrillation testing
Eligibility Criteria
You may qualify if:
- Subject must be undergoing surgical procedure for approved indications for:
- cardiothoracic surgery where a midline sternotomy is planned, or
- cardiothoracic surgery where a subxiphoid/paraxiphoid cut for a chest tube is planned, or
- VT ablation procedure with epicardial access, or
- implant of a subcutaneous ICD (S-ICD®), or implant of a transvenous ICD (single or dual chamber)
- Subject must be willing to provide Informed Consent
- Subject must be ≥ 18 years old
You may not qualify if:
- Subject has known hiatus hernia or moderate or worse pectus excavatum
- Subject had previous pericarditis or prior sternotomy
- Subject has known significant Right Ventricle/ Right Ventricular dilation
- Subject has hypertrophic cardiomyopathy
- Subject is pacemaker dependent
- Subject has known skin irritations due to the Covidien Multi-function defibrillation electrode
- Subject is considered to be at high risk for infection(1)
- Subject has Left Ventricular Ejection Fraction \< 20% (most recent available LVEF measurement in the last 6 months)
- Subject has New York Heart Association Class IV
- Subject has myocardial infarction within the last 6 weeks
- Subject currently has unstable angina
- Subject has severe aortic stenosis
- Subject at high risk of stroke (2)
- Subject has Chronic Obstructive Pulmonary Disease and is oxygen dependent
- Subject has permanent AF and will not be adequately anticoagulated during the ASD2 Acute Testing procedure (3)
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States
Hartford Hospital
Hartford, Connecticut, United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
Iowa Heart Center
Des Moines, Iowa, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Mayo Clinic (Rochester MN)
Rochester, Minnesota, United States
Lourdes Cardiology Services
Cherry Hill, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
New York-Presbytarian Hospital / Well Cornell Medical Center
New York, New York, United States
NYU Langone Medical Center
New York, New York, United States
Raleigh Cardiology Associates
Raleigh, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Austin Hospital
Heidelberg, Victoria, Australia
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Leuven - Campus Gasthuisberg
Leuven, Belgium
Royal Columbian Hospital
New Westminster, British Columbia, Canada
London Health Sciences Centre - University Campus
London, Ontario, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec, Canada
Prince of Wales Hospital
Kowloon, Hong Kong
Semmelweis University
Budapest, Hungary
Academisch Medisch Centrum (AMC)
Amsterdam, Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Christchurch Hospital
Christchurch, New Zealand
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, Poland
Slaskie Centrum Chorob Serca
Zabrze, Poland
Hospital Universitario Reina Sofia
Córdoba, Spain
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
King's College of London
London, United Kingdom
John Radcliffe Hospital Oxford
Oxford, United Kingdom
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2016
First Posted
May 13, 2016
Study Start
May 1, 2016
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
June 19, 2018
Record last verified: 2018-03