First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator Data

NCT01161589 | Completed

• 1 other identifier: FACTS S-ICD
• Study Type: observational
• Target: 142
• Locations: 2 countries
• Sites: 4

Brief Summary

The purpose of this clinical study is to collect simultaneous, multiple view cardiac signals representing both transvenous ICDs (T-ICD) and sensing vectors from the subcutaneous implantable defibrillator system (S-ICD). Upon completion, this data will represent the first true database capable of comparing detection characteristics of transvenous and subcutaneous ICDs. Future protocols will be created to dictate the specific methods of such comparisons.

Conditions

Ventricular Tachycardia; Ventricular Fibrillation; Atrial Fibrillation

Keywords

sensing; S-ICD; ICD; CRT D

Outcome Measures

Primary Outcomes (1)

• Collection of simultaneous cardiac signals representing S-ICD and ICD sensing vectors

  This study will enroll a sufficient number of patients such that a minimum of 50 atrial and 50 ventricular arrhythmic episodes are collected by dedicated and integrated ICD systems and by the simulated S-ICD system

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a routine dual chamber, dual high voltage shocking coil T-ICD or CRT-D insertion or replacement

You may qualify if:

• Age 18 or above, or legal age to give consent specific to state and national law.
• Any patient undergoing a clinically indicated initial dual chamber T-ICD or CRT-D implantation. In addition, patients who require replacement of an existing dual chamber T-ICD or CRT-D system will be eligible for enrollment in the study.
• Patient will have a subcutaneous, left pectoral defibrillator implant

You may not qualify if:

• Patients unable or unwilling to provide informed consent.
• Any condition which precludes the subject's ability to comply with the study requirements, including completion of the study.
• Patients in chronic atrial fibrillation who have not been in sinus rhythm within the last six months.
• Enrollment in a concurrent study, without Cameron Health's written approval, that may confound the results of this study.
• Women who are pregnant or who are trying to become pregnant Note: Women of child bearing potential must have a negative pregnancy test within 7 days prior to defibrillator implant.
• Patient requires left sub-muscular or right sided defibrillator implant

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (4)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Erasmus Medical Centre

Rotterdam, 3000 CA, Netherlands

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 12, 2010
• First Posted: July 13, 2010
• Study Start: October 1, 2005
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

NL (1); US (3)