Back to results

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

Primary Purpose

Heart Failure

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

AV Delay programming through cardiac resynchronization therapy

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, HF, Cardiac Resynchronization Therapy, CRT, Optimization, SmartDelay, Echocardiography, AV Delay

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical College of Virginia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Echo optimized AV delay

Algorithm optimized AV delay

Fixed AV Delay

Arm Description

Echo optimized AV delay

Algorithm optimized AV delay

Fixed AV Delay

Outcomes

Primary Outcome Measures

Left Ventricular End-systolic Volume (LVESV)

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

Full Information

NCT ID

NCT00677014

First Posted

May 9, 2008

Last Updated

April 17, 2013

Sponsor

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00677014

Brief Title

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

Acronym

SMART-AV

Official Title

SMARTDELAY Determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Scientific Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

1060 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Echo optimized AV delay

Arm Type

Active Comparator

Arm Description

Echo optimized AV delay

Arm Title

Algorithm optimized AV delay

Arm Type

Active Comparator

Arm Description

Algorithm optimized AV delay

Arm Title

Fixed AV Delay

Arm Type

Active Comparator

Arm Description

Fixed AV Delay

Intervention Type

Device

Intervention Name(s)

AV Delay programming through cardiac resynchronization therapy

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

AV Delay programming through cardiac resynchronization therapy

Intervention Description

Intervention Type

Device

Intervention Name(s)

AV Delay programming through cardiac resynchronization therapy

Intervention Description

Primary Outcome Measure Information:

Title

Left Ventricular End-systolic Volume (LVESV)

Description

Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Secondary Endpoints Will Include Structural and Functional Measures

Time Frame

Chronic

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

CRM Clinical Affairs

Organizational Affiliation

Boston Scientific Corporation

Official's Role

Study Director

Facility Information:

Facility Name

Medical College of Virginia

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298-0053

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

10368116

Citation

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.

Results Reference

background

PubMed Identifier

11923041

Citation

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.

Results Reference

background

PubMed Identifier

15671613

Citation

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.

Results Reference

background

PubMed Identifier

3839979

Citation

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.

Results Reference

background

PubMed Identifier

16784420

Citation

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.

Results Reference

background

PubMed Identifier

16520415

Citation

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.

Results Reference

background

PubMed Identifier

16891011

Citation

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.

Results Reference

background

PubMed Identifier

17449877

Citation

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.

Results Reference

background

PubMed Identifier

17826387

Citation

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.

Results Reference

background

PubMed Identifier

16950184

Citation

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.

Results Reference

background

PubMed Identifier

34706949

Citation

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.

Results Reference

derived

PubMed Identifier

34454883

Citation

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.

Results Reference

derived

PubMed Identifier

30476543

Citation

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.

Results Reference

derived

Links:

URL

http://www.bostonscientific.com

Description

Sponsor website

Learn more about this trial

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

We'll reach out to this number within 24 hrs