The Registry Evaluating Functional Outcomes of Resynchronization Management

Status unconfirmed

Conditions studied: Congestive Heart Failure

In brief

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 outcomes with electrophysiologic device therapy for chronic congestive heart failure.

Key facts

Study ID

NCT00959179

Run by

Saint Luke's Health System

People needed

100

Starts

2007-05-01

Expected to finish

2009-12-01

Last updated by the study team

2009-08-14

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Provena Saint Joseph Hospital — Elgin, Illinois, United States
• Oklahoma University Health Sciences Ctr. — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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