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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Echo optimized AV delay | Active Comparator | Echo optimized AV delay |
|
| Algorithm optimized AV delay | Active Comparator | Algorithm optimized AV delay |
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| Fixed AV Delay | Active Comparator | Fixed AV Delay |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AV Delay programming through cardiac resynchronization therapy | Device | All subjects in this trial receive the same device. For the purpose of this trial. "intervention" is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular End-systolic Volume (LVESV) | Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoints Will Include Structural and Functional Measures | Chronic |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CRM Clinical Affairs | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Virginia | Richmond | Virginia | 23298-0053 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10368116 | Background | Auricchio A, Stellbrink C, Block M, Sack S, Vogt J, Bakker P, Klein H, Kramer A, Ding J, Salo R, Tockman B, Pochet T, Spinelli J. Effect of pacing chamber and atrioventricular delay on acute systolic function of paced patients with congestive heart failure. The Pacing Therapies for Congestive Heart Failure Study Group. The Guidant Congestive Heart Failure Research Group. Circulation. 1999 Jun 15;99(23):2993-3001. doi: 10.1161/01.cir.99.23.2993. | |
| 11923041 |
| Label | URL |
|---|---|
| Sponsor website | View source |
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1060 patients were enrolled. 46 patients were not implanted with a CRT-D: screening failures (27), withdrawn by physician/sponsor (15) or withdrew consent (4). 34 implanted patients were not randomized: screening failures (13), withdrawn by physician/sponsor (14), withdrew consent (4), LTFU (2), death (1), not properly randomized (3)
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| ID | Title | Description |
|---|---|---|
| FG000 | Fixed AV Delay | Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0 |
| FG001 | Echo Optimized AV Delay | Echo optimized AV delay (Iterative Method), LV offset is optional |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AV Delay programming through cardiac resynchronization therapy | Device | All subjects in this trial receive the same device. For the purpose of this trial. "intervention" is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm. |
|
| AV Delay programming through cardiac resynchronization therapy | Device | All subjects in this trial receive the same device. For the purpose of this trial. "intervention" is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm. |
|
| Background |
| Auricchio A, Ding J, Spinelli JC, Kramer AP, Salo RW, Hoersch W, KenKnight BH, Klein HU. Cardiac resynchronization therapy restores optimal atrioventricular mechanical timing in heart failure patients with ventricular conduction delay. J Am Coll Cardiol. 2002 Apr 3;39(7):1163-9. doi: 10.1016/s0735-1097(02)01727-8. |
| 15671613 | Background | Inoue N, Ishikawa T, Sumita S, Nakagawa T, Kobayashi T, Matsushita K, Matsumoto K, Ohkusu Y, Taima M, Kosuge M, Uchino K, Kimura K, Umemura S. Long-term follow-up of atrioventricular delay optimization in patients with biventricular pacing. Circ J. 2005 Feb;69(2):201-4. doi: 10.1253/circj.69.201. |
| 3839979 | Background | Meisner JS, McQueen DM, Ishida Y, Vetter HO, Bortolotti U, Strom JA, Frater RW, Peskin CS, Yellin EL. Effects of timing of atrial systole on LV filling and mitral valve closure: computer and dog studies. Am J Physiol. 1985 Sep;249(3 Pt 2):H604-19. doi: 10.1152/ajpheart.1985.249.3.H604. |
| 16784420 | Background | Morales MA, Startari U, Panchetti L, Rossi A, Piacenti M. Atrioventricular delay optimization by doppler-derived left ventricular dP/dt improves 6-month outcome of resynchronized patients. Pacing Clin Electrophysiol. 2006 Jun;29(6):564-8. doi: 10.1111/j.1540-8159.2006.00402.x. |
| 16520415 | Background | Steendijk P, Tulner SA, Bax JJ, Oemrawsingh PV, Bleeker GB, van Erven L, Putter H, Verwey HF, van der Wall EE, Schalij MJ. Hemodynamic effects of long-term cardiac resynchronization therapy: analysis by pressure-volume loops. Circulation. 2006 Mar 14;113(10):1295-304. doi: 10.1161/CIRCULATIONAHA.105.540435. Epub 2006 Mar 6. |
| 16891011 | Background | Hardt SE, Yazdi SH, Bauer A, Filusch A, Korosoglou G, Hansen A, Bekeredjian R, Ehlermann P, Remppis A, Katus HA, Kuecherer HF. Immediate and chronic effects of AV-delay optimization in patients with cardiac resynchronization therapy. Int J Cardiol. 2007 Feb 14;115(3):318-25. doi: 10.1016/j.ijcard.2006.03.015. Epub 2006 Aug 7. |
| 17449877 | Background | Tournoux FB, Alabiad C, Fan D, Chen AA, Chaput M, Heist EK, Mela T, Mansour M, Reddy V, Ruskin JN, Picard MH, Singh JP. Echocardiographic measures of acute haemodynamic response after cardiac resynchronization therapy predict long-term clinical outcome. Eur Heart J. 2007 May;28(9):1143-8. doi: 10.1093/eurheartj/ehm050. Epub 2007 Apr 21. |
| 17826387 | Background | Vidal B, Sitges M, Marigliano A, Delgado V, Diaz-Infante E, Azqueta M, Tamborero D, Tolosana JM, Berruezo A, Perez-Villa F, Pare C, Mont L, Brugada J. Optimizing the programation of cardiac resynchronization therapy devices in patients with heart failure and left bundle branch block. Am J Cardiol. 2007 Sep 15;100(6):1002-6. doi: 10.1016/j.amjcard.2007.04.046. Epub 2007 Jul 5. |
| 16950184 | Background | Kedia N, Ng K, Apperson-Hansen C, Wang C, Tchou P, Wilkoff BL, Grimm RA. Usefulness of atrioventricular delay optimization using Doppler assessment of mitral inflow in patients undergoing cardiac resynchronization therapy. Am J Cardiol. 2006 Sep 15;98(6):780-5. doi: 10.1016/j.amjcard.2006.04.017. Epub 2006 Jul 28. |
| 34706949 | Derived | Howell S, Stivland TM, Stein K, Ellenbogen K, Tereshchenko LG. Response to cardiac resynchronisation therapy in men and women: a secondary analysis of the SMART-AV randomised controlled trial. BMJ Open. 2021 Oct 27;11(10):e049017. doi: 10.1136/bmjopen-2021-049017. |
| 34454883 | Derived | Howell SJ, Stivland T, Stein K, Ellenbogen KA, Tereshchenko LG. Using Machine-Learning for Prediction of the Response to Cardiac Resynchronization Therapy: The SMART-AV Study. JACC Clin Electrophysiol. 2021 Dec;7(12):1505-1515. doi: 10.1016/j.jacep.2021.06.009. Epub 2021 Aug 25. |
| 30476543 | Derived | Spinale FG, Meyer TE, Stolen CM, Van Eyk JE, Gold MR, Mittal S, DeSantis SM, Wold N, Beshai JF, Stein KM, Ellenbogen KA; SMART-AV Trial Investigators. Development of a biomarker panel to predict cardiac resynchronization therapy response: Results from the SMART-AV trial. Heart Rhythm. 2019 May;16(5):743-753. doi: 10.1016/j.hrthm.2018.11.026. Epub 2018 Nov 24. |
| FG002 | Algorithm Optimized AV Delay | Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fixed AV Delay | Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0 |
| BG001 | Echo Optimized AV Delay | Echo optimized AV delay (Iterative Method), LV offset is optional |
| BG002 | Algorithm Optimized AV Delay | Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Left Ventricular End-systolic Volume (LVESV) | Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up | Availability of baseline and 6 month echocardiograms with primary endpoint values (LVESV) among randomized patients | Posted | Median | Inter-Quartile Range | ml | 6 months |
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| Secondary | Secondary Endpoints Will Include Structural and Functional Measures | Not Posted | Chronic |
Adverse event data were collected from randomization through the 6-month follow-up visit. Per trial design, serious adverse events were not collected in this trial.
Source vocabulary for AE coding was not used in this trial. Serious adverse events were not collected in this trial per trial design.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fixed AV Delay | Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0 | 0 | 0 | 145 | 325 | ||
| EG001 | Echo Optimized AV Delay | Echo optimized AV delay (Iterative Method), LV offset is optional | 0 | 0 | 145 | 323 | ||
| EG002 | Algorithm Optimized AV Delay | Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0 | 0 | 0 | 144 | 332 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PG Related | Cardiac disorders | Systematic Assessment |
| ||
| RA Lead Related | Cardiac disorders | Systematic Assessment |
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| RV Lead Related | Cardiac disorders | Systematic Assessment |
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| Procedure Related | Cardiac disorders | Systematic Assessment |
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| LV Lead Related | Cardiac disorders | Systematic Assessment |
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| Cardiovascular Related | Cardiac disorders | Systematic Assessment |
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| Death not related to any of the other Adverse Event categories | Cardiac disorders | Systematic Assessment |
| ||
| Non-Cardiovascular | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Greg Voss, Clinical Director | Boston Scientific | 651-581-3068 | gregory.voss@bsci.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Europe |
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