Clinical trial NCT02772380: Acute Study to Collect Electrical Signals From the Heart Using a Special Lead
Official title: Acute Extravascular Defibrillation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tachycardia
Ventricular Arrhythmias
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2016-05-13
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* Subject with an implanted active cardiac or non-cardiac device during the ASD2 Acute Testing procedure (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator)
* Subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
* Subject has any medical condition that would limit study participation
* Subject is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to the ASD2 Acute Testing procedure
* Subject meets exclusion criteria required by local law (e.g. age, breast feeding,etc.)
* Subject is legally incompetent

  1. Screening subjects at high risk for infection will be based on the local investigator judgment decision.
  2. Subjects who are at high risk for stroke should be screened according to local country guidelines or, in case of their absence, according to ACC/AHA/ESC 2006 Guidelines for High Risk Factors for Stroke (i.e. exclusion of subjects with previous stroke, TIA, or embolism; Mitral stenosis; prosthetic heart valve).
  3. Screening will be based on the local investigator judgment decision.

Primary outcomes:
measure: Number of extravascular electrograms collected during ventricular fibrillation or ventricular tachycardia episodes
timeFrame: Day of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Arrhythmia Consultants
state: Arizona
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Jacksonville
country: United States
facility: Baptist Medical Center Jacksonville
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic (Rochester MN)
state: Minnesota
city: Cherry Hill
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: New York
country: United States
facility: New York-Presbytarian Hospital / Well Cornell Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Raleigh
country: United States
facility: Raleigh Cardiology Associates
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre - University Campus
state: Ontario
city: Quebec City
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
state: Quebec
city: Kowloon
country: Hong Kong
facility: Prince of Wales Hospital
city: Budapest
country: Hungary
facility: Semmelweis University
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum (AMC)
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Kraków
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II
city: Zabrze
country: Poland
facility: Slaskie Centrum Chorob Serca
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: London
country: United Kingdom
facility: King's College of London
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital Oxford
city: Southampton
country: United Kingdom
facility: Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Study officials:
References: