Status:
UNKNOWN
The Registry Evaluating Functional Outcomes of Resynchronization Management
Lead Sponsor:
Saint Luke's Health System
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18-90 years
Brief Summary
The purpose of this study is to evaluate the functional outcomes of resynchronization management and to describe the patient psychosocial characteristics (depression ad anxiety) and associated outcome...
Detailed Description
This project will prospectively enroll all consecutive patients undergoing implantable cardioverter defibrillator (ICD) and ICD with biventricular pacemaker (CRT-D) implantation for heart failure from...
Eligibility Criteria
Inclusion
- Patients implanted with ICD who meet Primary prevention (SCD-HeFT or MADIT II indications.
- Patients implanted with CRT-D indications (i.e. NYHA class III or IV; QRS \> = to 120MS; LVEF \<= TO 35%) patient willing to give informed consent and participate in follow up evaluation.
Exclusion
- Non-English speaking patients and patients who are unable to give consent or participate in follow up protocols due to lack of a home phone or unwilling to disclose phone numbers.
- Patients with significant transient neurological impairment before, during or after device implant who have been deemed incompetent to complete the consent process, or who are unable to participate in follow-up evaluation tests.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00959179
Start Date
May 1 2007
End Date
December 1 2009
Last Update
August 14 2009
Active Locations (2)
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1
Provena Saint Joseph Hospital
Elgin, Illinois, United States, 60123
2
Oklahoma University Health Sciences Ctr.
Oklahoma City, Oklahoma, United States