The Registry Evaluating Functional Outcomes of Resynchronization Management
REFORM
1 other identifier
observational
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2007
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 13, 2009
CompletedFirst Posted
Study publicly available on registry
August 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedAugust 14, 2009
August 1, 2009
2.6 years
August 13, 2009
August 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare the psysocial function and quality of life of ICD patients receiving CRT with ICD therapy
3 months and 9 month follow up
Secondary Outcomes (1)
Compare change in LVED&LVESV in CRT and ICD patients. Determine/compare the change in NYHA class, KCCQ, optimism/pessimism, degree of stress,social support. Florida Shock Anxiety Scale & clinical composite score determined and compared at 3 and 9 month
9 month follow up
Study Arms (2)
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
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
Eligibility Criteria
Population from In-patient and out patient setting
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Provena Saint Joseph Hospital
Elgin, Illinois, 60123, United States
Oklahoma University Health Sciences Ctr.
Oklahoma City, Oklahoma, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian M Ramza, MD
Cardiovascular Consultants PA
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 13, 2009
First Posted
August 14, 2009
Study Start
May 1, 2007
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
August 14, 2009
Record last verified: 2009-08