Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Boston Scientific Corporation |
---|---|
Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00677014 |
The primary objective of SMART-AV is to assess the effect of SmartDelay for determining optimal AV delay timing during CRT compared to both a fixed AV delay and echocardiography-determined optimal AV timing chronically over a 6-month period.
Condition | Intervention | Phase |
---|---|---|
Heart Failure |
Other: Fixed nominal AV delay Other: Echo optimized AV delay Other: Algorithm optimized AV delay |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment |
Official Title: | SMARTDELAY Determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy |
Estimated Enrollment: | 950 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | December 2010 |
Arms | Assigned Interventions |
---|---|
1
Fixed nominal AV delay
|
Other: Fixed nominal AV delay |
2
Echo optimized AV delay
|
Other: Echo optimized AV delay |
3
Algorithm optimized AV delay
|
Other: Algorithm optimized AV delay |
SMART-AV is a randomized, multi-center, double-blinded, non-significant risk, three-armed trial that will investigate the effects of optimizing AV delay timing in heart failure patients receiving CRT-D therapy. Patients will be randomized in a 1:1:1 ratio using randomly permuted blocks within each center. The study will compare chronic changes in structural and functional outcomes in CRT-D patients randomized to AV delay set as fixed, set with SmartDelay or determined by echocardiography. Patients will be followed at enrollment, implant, post-implant, 3-months post-implant and 6-months post-implant.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
The New York Presbyterian Hospital - Weill Cornell Med Ctr | Recruiting |
New York, New York, United States | |
Contact: Kenneth M Stein, MD kstein@med.cornell.edu | |
Principal Investigator: Kenneth M Stein, MD |
Study Director: | CRM Clinical Affairs | Boston Scientific Corporation |
Responsible Party: | Boston Scientific CRM ( Boston Scientific CRM ) |
Study ID Numbers: | CR-CA-050508-H |
Study First Received: | May 9, 2008 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00677014 |
Health Authority: | United States: Institutional Review Board; Europe: Ethics Review Board |
Heart Failure HF Cardiac Resynchronization Therapy CRT |
Optimization SmartDelay Echocardiography AV Delay |
Heart Failure Heart Diseases |
Cardiovascular Diseases |