Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT) - Full Text View

Purpose

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	Device: AV Delay programming through cardiac resynchronization therapy	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	SMARTDELAY Determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

Left Ventricular End-systolic Volume (LVESV) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up

Secondary Outcome Measures:

Secondary Endpoints Will Include Structural and Functional Measures [ Time Frame: Chronic ] [ Designated as safety issue: No ]

Enrollment:	1060
Study Start Date:	May 2008
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Echo optimized AV delay Echo optimized AV delay	Device: AV Delay programming through cardiac resynchronization therapy 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.
Active Comparator: Algorithm optimized AV delay Algorithm optimized AV delay	Device: AV Delay programming through cardiac resynchronization therapy 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.
Active Comparator: Fixed AV Delay Fixed AV Delay	Device: AV Delay programming through cardiac resynchronization therapy 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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677014

Locations

United States, Virginia
Medical College of Virginia
Richmond, Virginia, United States, 23298-0053

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Study Director:

CRM Clinical Affairs

Boston Scientific Corporation

More Information

Additional Information:

Sponsor website This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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.

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.

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. Epub 2006 Mar 6.

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. Epub 2006 Aug 7.

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. Epub 2007 Apr 21.

Vidal B, Sitges M, Marigliano A, Delgado V, Díaz-Infante E, Azqueta M, Tamborero D, Tolosana JM, Berruezo A, Pérez-Villa F, Paré 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. Epub 2007 Jul 5.

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. Epub 2006 Jul 28.

Responsible Party:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00677014 History of Changes
Other Study ID Numbers:	CR-CA-050508-H
Study First Received:	May 9, 2008
Results First Received:	July 27, 2012
Last Updated:	April 17, 2013
Health Authority:	United States: Institutional Review Board Germany: Ethics Commission Spain: Ethics Committee United Kingdom: Research Ethics Committee

Keywords provided by Boston Scientific Corporation:

Heart Failure
HF
Cardiac Resynchronization Therapy
CRT

Optimization
SmartDelay
Echocardiography
AV Delay

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013

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