Acute Study to Collect Electrical Signals From the Heart Using a Special Lead

Tachycardia Clinical Trial

Official title:

Acute Extravascular Defibrillation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02772380
• Other study ID #: ASD2
• Secondary ID: U1111-1179-2213
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: August 2017

Study information

• Verified date: March 2018
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tachycardia
• Ventricular Arrhythmias

Intervention

Device:
• Defibrillation following induction of VT/VF
Up to 10 attempts to induce two VF/VT episodes for defibrillation testing

Locations

Country	Name	City	State
Australia	Austin Hospital	Heidelberg	Victoria
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	UZ Leuven - Campus Gasthuisberg	Leuven
Canada	London Health Sciences Centre - University Campus	London	Ontario
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)	Quebec City	Quebec
Hong Kong	Prince of Wales Hospital	Kowloon
Hungary	Semmelweis University	Budapest
Netherlands	Academisch Medisch Centrum (AMC)	Amsterdam
Netherlands	Maastricht Universitair Medisch Centrum	Maastricht
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
New Zealand	Christchurch Hospital	Christchurch
Poland	Krakowski Szpital Specjalistyczny im. Jana Pawla II	Kraków
Poland	Slaskie Centrum Chorob Serca	Zabrze
Spain	Hospital Universitario Reina Sofia	Cordoba
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United Kingdom	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 States	University of Maryland Medical Center	Baltimore	Maryland
United States	Lourdes Cardiology Services	Cherry Hill	New Jersey
United States	Northwestern University	Chicago	Illinois
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Iowa Heart Center	Des Moines	Iowa
United States	Hartford Hospital	Hartford	Connecticut
United States	Baptist Medical Center Jacksonville	Jacksonville	Florida
United States	Lancaster General Hospital	Lancaster	Pennsylvania
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	Mayo Clinic (Rochester MN)	Rochester	Minnesota
United States	Arizona Arrhythmia Consultants	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Hong Kong,  Hungary,  Netherlands,  New Zealand,  Poland,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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