Status:
COMPLETED
Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study
Lead Sponsor:
Guidant Corporation
Collaborating Sponsors:
University of Rochester
Conditions:
Sudden Cardiac Death
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
This study has 2 purposes: The first purpose of the study is to test a new family of Boston Scientific Implantable Cardioverter Defibrillators ("ICDs") and cardiac resynchronization therapy ICDs ("CR...
Detailed Description
Study Purpose Study purpose I: To evaluate and document appropriate clinical performance of the INCEPTA (DR and VR) implantable cardioverter defibrillator (ICD) system and the INCEPTA cardiac resync...
Eligibility Criteria
Inclusion
- Patients who are willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical study;
- Patients whose age is 18 or above, or of legal age to give informed consent specific to national law
- Patients indicated for an ICD according to normal clinical practice (for those patients receiving an INCEPTA ICD).
- As soon as 20 ICD patients are included in the study for purpose I, only NYHA Class III patients will be allowed in the study.
- New York Heart Association (NYHA) Class III patients indicated for a CRT-D according to normal clinical practice (for those patients receiving an INCEPTA CRT-D).
Exclusion
- Women of childbearing potential who are or might be pregnant at the time of the study (method of assessment upon physician's discretion)
- Enrolled in any other concurrent study.
- Inability or refusal to comply with the follow-up schedule
- Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days
- Patients prescribed to positive airway pressure therapy
- A life expectancy of less than 1 year, per physician discretion
- Patient in NYHA Class IV during the last 4 weeks
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01227785
Start Date
October 1 2010
End Date
December 1 2011
Last Update
April 25 2014
Active Locations (1)
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1
Deutsches Herzzentrum Berlin
Berlin, State of Berlin, Germany