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

Completed · Not applicable

Conditions studied: Tachycardia, Ventricular Arrhythmias

In brief

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.

Key facts

Study ID

NCT02772380

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

87

Starts

2016-05-01

Expected to finish

2017-08-01

Last updated by the study team

2018-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)
• 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
• Screening subjects at high risk for infection will be based on the local investigator judgment decision.
• 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).
• Screening will be based on the local investigator judgment decision.

Where it is running

• 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

Full record on ClinicalTrials.gov

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