Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT)

NCT00677014 | Completed Phase 4 Results

• 1 other identifier: CR-CA-050508-H
• Study Type: interventional
• Target: 1,060
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Heart Failure; HF; Cardiac Resynchronization Therapy; CRT; Optimization; SmartDelay; Echocardiography; AV Delay

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Secondary Endpoints Will Include Structural and Functional Measures

  Chronic

Study Arms (3)

Echo optimized AV delay

ACTIVE COMPARATOR

Echo optimized AV delay

Device: AV Delay programming through cardiac resynchronization therapy

Algorithm optimized AV delay

ACTIVE COMPARATOR

Algorithm optimized AV delay

Device: AV Delay programming through cardiac resynchronization therapy

Fixed AV Delay

ACTIVE COMPARATOR

Fixed AV Delay

Device: AV Delay programming through cardiac resynchronization therapy

Interventions

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.

Fixed AV Delay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet current indications for a BSC CRT-D device with the SmartDelay algorithm
• Patients who are willing and capable of undergoing a device implant and participating in all testing associated with the SMART-AV Study
• Patients who are on optimal and stable pharmacologic therapy
• Patients who are expected to be in sinus rhythm at the time of implant
• Patients who have a life expectancy of more than 360 days, per physician's discretion
• Patients who are geographically stable and willing to comply with the required follow-up schedule
• Patients who are 18 years of age or above, or of legal age to give informed consent specific to state and national law

You may not qualify if:

• Patients who are in complete heart block, or who otherwise are unable to tolerate pacing at VVI-40 RV for up to 14 days
• Patients undergoing an upgrade of a pacemaker or implantable cardioverter-defibrillator who are unable to tolerate pacing at VVI-40 RV for up to 14 days
• Patients who have previously received cardiac resynchronization therapy
• Patients who are expected to receive a heart transplant or have other cardiac surgeries or procedures planned during the course of the study
• Patients who currently have or who are likely to receive a tricuspid valve prosthesis
• Patients who have a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking
• Patients who are pregnant or planning to become pregnant during the study
• Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Medical College of Virginia

Richmond, Virginia, 23298-0053, United States

Location

Related Publications (13)

• 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.

  PMID: 10368116 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.

  PMID: 11923041 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.

  PMID: 15671613 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.

  PMID: 3839979 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.

  PMID: 16784420 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.

  PMID: 16520415 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.

  PMID: 16891011 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.

  PMID: 17449877 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.

  PMID: 17826387 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.

  PMID: 16950184 BACKGROUND

• 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.

  PMID: 34706949 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.

  PMID: 34454883 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.

  PMID: 30476543 DERIVED

Related Links

• Sponsor website

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Greg Voss, Clinical Director
• Organization: Boston Scientific

gregory.voss@bsci.com

651-581-3068

Study Officials

• CRM Clinical Affairs

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2008
• First Posted: May 13, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: April 24, 2013
• Results First Posted: August 30, 2012

Record last verified: 2013-04

Locations

US (1)