The Registry Evaluating Functional Outcomes of Resynchronization Management

NCT ID: NCT00959179

Last Updated: 2009-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-12-31

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 outcomes with electrophysiologic device therapy for chronic congestive heart failure.

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 in-patient and out-patient setting. Primary objective: Compare the psychosocial function and quality of life of ICD patients to Patients receiving CRT-D therapy. Secondary outcome objectives: 1)Determine and compare the change in LVED (left ventricular end distolic) dimension and LVESV (left ventricular end systolic volume)from baseline to 9 month follow up in CRT and ICD patient.2)Determine and compare the change in NYHA (New York Heart Association) classification, KCCQ, optimisim and pessimism, degree of stress, and social support from baseline to 9 month follow up in CRT and ICD patients. Florida Patient Acceptance Survey and Florida Shock Anxiety Scale will be determined and compared at 3 monthe and 9 months.3)Determine and compare Clinical composite score(Packer M 2002)in patient groups where: Worsened-patient dies, improved, unchanged. Inclusion Criteria: Patient referred for device therapy (ICD or CRT-D) for chronic congestive heart failure who are willing and able to give informed consent and participate in follow-up calls. Duration of patient follow up will be 9 months. Statistical Mehtodology: Univariate, Multivariatae, Kaplan-Meier analysis

Conditions

Congestive Heart Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Device therapy patients for CHF.

enroll all consecutive patients undergoing implantable cardioverter defibrillator (ICD) and ICD with biventricular pacemaker (CRT-D) implantation for heart failure from in-patient and out-patient referral setting

No interventions assigned to this group

ICD and CRT-D patients

enroll all consecutive patients undergoing implantable cardioverter defibrillator (ICD) and ICD with biventricular pacemaker (CRT-D) implantation for heart failure from in-patient and out-patient referral setting

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint Luke's Health System

OTHER

Sponsor Role: lead

Responsible Party

Saint Luke's Hospital

Principal Investigators

Brian M Ramza, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Consultants PA

Locations

Provena Saint Joseph Hospital

Elgin, Illinois, United States

Oklahoma University Health Sciences Ctr.

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

REFORM

Identifier Type: -

Identifier Source: org_study_id