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COMPLETEDNA

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

Acute Extravascular Defibrillation Study

NCT02772380•Medtronic Cardiac Rhythm and Heart Failure

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+13 more criteria

Locations (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

Key Dates

Start Date

May 1, 2016

Primary Completion Date

August 1, 2017

Completion Date

August 1, 2017

Last Updated

June 19, 2018

Enrollment

ACTUAL participants

Conditions

TachycardiaVentricular Arrhythmias

Interventions

Defibrillation following induction of VT/VF

DEVICE

Study of Natriuretic Peptide Receptor 1 (NPR1) Antagonist in Adult Patients With Postural Orthostatic Tachycardia Syndrome (POTS)

NCT06593600

Postural Orthostatic Tachycardia Syndrome (POTS)

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RECRUITINGNA

Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions

NCT06743789

Ventricular Tachycardia

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RECRUITINGNA

Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 19, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of Natriuretic Peptide Receptor 1 (NPR1) Antagonist in Adult Patients With Postural Orthostatic Tachycardia Syndrome (POTS)

Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions

Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome

Safety, Tolerability, and Exploratory Efficacy of AGP100 in Patients With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm

POLish Registry of CArdioneuroablation and CArdioneuromodulation