SmartDelay determined AV optimization: a comparison of AV delay methods used in cardiac resynchronization therapy (SMART-AV): rationale and design.
Background: The clinical benefit of cardiac resynchronization therapy (CRT) for patients with moderate-to-severely symptomatic heart failure, left ventricular systolic dysfunction, and ventricular conduction delay is established. However, some patients do not demonstrate clinical improvement followi...
| Published in: | Pacing & Clinical Electrophysiology Vol. 33; no. 1; pp. 54 - 64 |
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| Main Authors: | , , , , , , , , , |
| Format: | research tables/charts Journal Article |
| Published: |
Wiley-Blackwell
Jan2010
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=105277903&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 105277903 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 01478389 4F8 jtl: Pacing & Clinical Electrophysiology issn: 01478389 maglogo: Y pubinfo: dt: Jan2010 vid: 33 iid: 1 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 105277903 2010519919 10.1111/j.1540-8159.2009.02581.x NLM19821938 105277903 ppf: 54 ppct: 10 formats: fmt: @attributes: type: P tig: atl: SmartDelay determined AV optimization: a comparison of AV delay methods used in cardiac resynchronization therapy (SMART-AV): rationale and design. aug: au: Stein KM Ellenbogen KA Gold MR Lemke B Lozano IF Mittal S Spinale FG Van Eyk JE Waggoner AD Meyer TE affil: Department of Medicine, Maurice & Corinne Greenberg Division of Cardiology, Weill Medical College of Cornell University, New York, NY; kenneth.stein@bsci.com sug: subj: Atrioventricular Node Physiopathology Cardiac Resynchronization Therapy Methods Cardiac Surgery Methods Biological Markers Data Analysis Methods Electrophysiology Heart Diseases Classification Heart Ventricle, Left Physiopathology ab: Background: The clinical benefit of cardiac resynchronization therapy (CRT) for patients with moderate-to-severely symptomatic heart failure, left ventricular systolic dysfunction, and ventricular conduction delay is established. However, some patients do not demonstrate clinical improvement following CRT. It is unclear whether systematic optimization of the programmed atrioventricular (AV) delay improves the rate of clinical response. Methods: SMART-AV is a randomized, multicenter, double-blinded, three-armed trial that will investigate the effects of optimizing AV delay timing in heart failure patients receiving CRT + defibrillator (CRT-D) therapy. A minimum of 950 patients will be randomized in a 1:1:1 ratio using randomly permuted blocks within each center programmed to either DDD or DDDR with a lower rate of 60. The study will include echocardiographic measurements of volumes and function [e.g., left ventricular end-systolic volume (LVESV)], biochemical measurements of plasma biomarker profiles, and functional measurements (e.g., 6-minute hall walk) in CRT-D patients who are enrolled and randomized to fixed AV delay (i.e., 120 ms), AV delay determined by electrogram-based SmartDelay, or an AV delay determined by echocardiography (i.e., mitral inflow). Patients will be evaluated prior to initiation of CRT, 3 and 6 months post-implant. The primary endpoint is the relative change in LVESV at 6 months between the groups. Patient enrollment commenced in May 2008 and the study is registered at clinicaltrials.gov. Conclusion: SMART-AV is a randomized, clinical trial designed to evaluate three different methods of AV delay optimization to determine whether systematic AV optimization is beneficial for patients receiving CRT for 6 months post-implant. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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