First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator Data (FACTS)

This study has been completed.
Sponsor:
Information provided by:
Cameron Health, Inc.
ClinicalTrials.gov Identifier:
NCT01161589
First received: July 12, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition
Ventricular Tachycardia
Ventricular Fibrillation
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator Data

Resource links provided by NLM:


Further study details as provided by Cameron Health, Inc.:

Primary Outcome Measures:
  • Collection of simultaneous cardiac signals representing S-ICD and ICD sensing vectors [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 intregrated ICD systems and by the simulated S-ICD system


Enrollment: 142
Study Start Date: October 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Detailed Description:

The FACTS S-ICD study is a data gathering study that takes place during the implant procedure of a standard T-ICD system. Patients undergoing a routine dual chamber, dual high voltage shocking coil T-ICD or CRT-D insertion or replacement will be connected to an external data recorder via sterile cables. Atrial and ventricular arrhythmias will be induced while multiple ECG views are simultaneously recorded from both intracardiac and surface vectors. These episodes will then be digitized to create the FACTS S-ICD arrhythmia library.

As both dedicated and integrated bipolar sensing configurations are currently utilized in the marketplace, data will be collected using both market available ICD sensing methods.

The FACTS S-ICD study will enroll a sufficient quantity of patients such that a minimum of 50 atrial and 50 ventricular arrhythmic episodes are collected via both dedicated and integrated ICD systems. S-ICD signals will be collected for all recorded episodes.

The T-ICD implant procedure will be completed as per normal hospital practice and no further patient dependent data gathering will be required past the implant surgery and point of surgery arrhythmia inductions.

INCLUSION CRITERIA

  1. Age 18 or above, or legal age to give consent specific to state and national law.
  2. 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.
  3. Patient will have a subcutaneous, left pectoral defibrillator implant.

EXCLUSION CRITERIA

  1. Patients unable or unwilling to provide informed consent.
  2. Any condition which precludes the subject's ability to comply with the study requirements, including completion of the study.
  3. Patients in chronic atrial fibrillation who have not been in sinus rhythm within the last six months.
  4. Enrollment in a concurrent study, without Cameron Health's written approval, that may confound the results of this study.
  5. 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.
  6. Patient requires left sub-muscular or right sided defibrillator implant
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161589

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Netherlands
Erasmus Medical Centre
Rotterdam, Netherlands, 3000 CA
Sponsors and Collaborators
Cameron Health, Inc.
  More Information

No publications provided

Responsible Party: Linda Smith, Cameron Health
ClinicalTrials.gov Identifier: NCT01161589     History of Changes
Other Study ID Numbers: FACTS S-ICD
Study First Received: July 12, 2010
Last Updated: July 12, 2010
Health Authority: United States: Institutional Review Board
Netherlands: Dutch Health Care Inspectorate

Keywords provided by Cameron Health, Inc.:
sensing
S-ICD
ICD
CRT D

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014