Heart Failure Clinical Trial
— BENEFITOfficial title:
Risk Stratification and Benefits With Cardiac Resynchronization Therapy
NCT number | NCT00996086 |
Other study ID # | CRD 480 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 2010 |
Est. completion date | September 2012 |
Verified date | February 2019 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is an observational study to learn which patients benefit from CRT therapy and to track the clinical changes that help identify the risk-level of CRT patients.
Status | Completed |
Enrollment | 154 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Meets current clinical indications for CRT-D therapy - Patient is 18 years old or older - Ability to independently comprehend and complete all QOL questionnaires - Patient has the ability to perform the 6-minute Hall Walk Test (6-MHW) with the only limiting factor being fatigue or shortness-of-breath - Ability to provide informed consent for a study and be willing and able to comply with the prescribed follow-up Exclusion Criteria: - Inability to successfully implant an intravascular lead and CRT-D device. (i.e. exclude epicardial leads) within 30 days of initial procedure. - Myocardial infarction in the last 3 weeks - Unstable angina in the last 3 weeks - Status 1 classification for cardiac transplantation - Currently participating in a clinical trial that includes an active treatment arm - Life expectancy of less than 12 months. - Recent (within 1 week) administration of Nesiritideā¢ or inotropes - Patients in whom revascularization is expected - Patient is pregnant |
Country | Name | City | State |
---|---|---|---|
United States | Touro College | New York | New York |
United States | Veterans' Adminstration Pittsburgh Healthcare System | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices | Northwestern University, VA Pittsburgh Healthcare System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in 6-minute hall walk distance between baseline and subsequent follow-up | 12 months | ||
Primary | Composite endpoint a. 6-minute hall walk distance b. NYHA Classification c. Quality of Life (Minnesota Living with Heart Failure, DASS, SF-36) | 12 months | ||
Primary | The occurrence of either death (all-cause) or first HF hospitalization. | 12 months | ||
Secondary | Quality of Life | 12 months | ||
Secondary | Change in echocardiographic variables including: a. Ejection Fraction b. Wall motion score c. Increase in TD velocity d. Yu index | 12 months | ||
Secondary | Cause-specific mortality | 12 months |
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