Strategic Management to Optimize Response To Cardiac Resynchronization Therapy (SMART CRT)

The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: CRT-D

Detailed Description

The primary hypothesis of SMART CRT is that among cardiac resynchronization therapy defibrillator (CRT-D) patients with prolonged inrerventricular delay between the RV and LV leads, CRT with atrioventricular optimization (AVO) will result in greater reverse LV remodeling compared with CRT programmed at nominal settings (120 ms).

• Study Type: Interventional
• Enrollment (Actual): 699
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada
    • Institut Universitaire de cardiologie et de pneumologie de Quebec
• France
  • Aix en Provence, France, 13616
    • Centre Hospitalier du Pays d'Aix
  • Grenoble, France, 38043
    • CHU Grenoble
  • Lille, France, 59037
    • CHRU de Lille
  • Lille, France, 59160
    • Hôpital Saint Philibert
  • Rennes, France, 35000
    • CHRU Hopital Pontchaillou
  • Rouen, France, 76031
    • Centre Hôpital Universitaire Rouen, Hôpital Charles Nicolle
  • Toulouse, France, 31059
    • Centre Hôpital Universitaire Rangueil
• Germany
  • Berlin, Germany, 12683
    • Unfalkrankenhaus Marzahn
  • Berlin, Germany, 13353
    • University of Berlin, Charite Virchow Standort
  • Jena, Germany, 07747
    • Uni Jena
  • Landshut, Germany, 84036
    • Krankenhaus Landshut-Achdorf
  • Magdeburg, Germany, 39120
    • Otto-von-Guericke-Universitaet Magdeburg
• Ireland
  • Dublin, Ireland, D07 R2WY
    • Mater Misericordiae University Hospital
• Italy
  • Bologna, Italy, 40138
    • Ospedale S. Orsola - Malpighi
  • Trieste, Italy, 34129
    • Azienda Sanitaria Universtitaria Integrata di Trieste
• Japan
  • Nagano, Japan
    • Shinshu University Hospital
  • Aomori
    • Hirosaki-shi, Aomori, Japan, 036-8562
      • Hirosaki University Hospital
  • Hiroshima
    • Hiroshima-shi, Hiroshima, Japan, 734-8530
      • Hiroshima Prefectural Hospital
  • Tokyo
    • Shinjuku-Ku, Tokyo, Japan, 162-8666
      • Tokyo Medical University Hospital
• Netherlands
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Ziekenhuis
• Spain
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre Madrid
  • Valencia, Spain, 46026
    • Hospital Universitario La Fe
  • Extremadura
    • Badajoz, Extremadura, Spain, 06080
      • Hospital Infanta Cristina
• Switzerland
  • Lugano, Switzerland, CH-6900
    • Cardiocentro Ticino
• United Kingdom
  • Brighton, United Kingdom, BN2 5BE
    • Royal Sussex County Hospital
  • Cardiff, United Kingdom, CF144XW
    • University Hospital of Wales
  • London, United Kingdom, W12 0HS
    • Hammersmith Hospital
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • Freeman Hospital
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham University Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton University Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Affinity Hospital, LLC d/b/a Granview Medical Center
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research LLC
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Sarver Heart Center
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Cardiology Associates of NE Arkansas
  • California
    • Glendale, California, United States, 91206
      • Glendale Adventist Medical Center
    • Salinas, California, United States, 93901
      • Salinas Valley Memorial Healthcare System
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health Services
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Health Research Institute
    • Lakeland, Florida, United States, 33805
      • Watson Clinic Center for Research, Inc
    • Winter Haven, Florida, United States, 33881
      • Winter Haven Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago
    • Springfield, Illinois, United States, 62701
      • St. John's Hospital
  • Indiana
    • Newburgh, Indiana, United States, 47630
      • Heart Group at Deaconness Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Healthcare
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital and Medical Center
    • Fall River, Massachusetts, United States, 02720
      • Southcoast Health
  • Michigan
    • Roseville, Michigan, United States, 48066
      • Cardiovascular Institute of Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Trinity Health Michigan D/B/A Michigan Heart
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • HealthEast St. Joseph's Hospital
  • Montana
    • Missoula, Montana, United States, 59802
      • The International Heart Institute on Montana Foundation
  • New Jersey
    • Haddon Heights, New Jersey, United States, 08035
      • Cardiovascular Associates of the Delaware Valley
    • Paramus, New Jersey, United States, 07652
      • The Valley Hospital
  • New York
    • Brooklyn, New York, United States, 11215
      • New York Methodist Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Heart and Vascular Institute
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Forsyth Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43215
      • The Ohio Health Research Institute- Grant Medical Center
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Heart Institute
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Clinic
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pottstown, Pennsylvania, United States, 19464
      • Pottstown Medical Specialist, Inc
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • North Central Heart
  • Texas
    • Dallas, Texas, United States, 75216
      • Dallas VA Research Corporation
    • Houston, Texas, United States, 77030
      • Michael E. DeBakey VA Medical Center
    • San Antonio, Texas, United States, 78229
      • Foundation for Advancing Veterans' Health Research
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University Medical Center
  • Washington
    • Vancouver, Washington, United States, 98664
      • PeaceHealth Southwest Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject must be indicated to receive a de novo quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) in conjunction with an ACUITY X4 LV lead. This includes subjects who are indicated to receive an upgrade to a BSC X4 CRT-D from a previously implanted device.

• In order to achieve a homogenous population for the study, qualifying subjects are those with heart failure who meet BSC US indications for use defined as those subjects who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications:

  • Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms
  • Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure
• Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws
• Subject is willing and capable of providing informed consent
• Subject is willing and capable of complying with visits and procedures as defined by this protocol

Exclusion Criteria:

• Subjects with documented permanent complete AV block
• Subjects with permanent or chronic atrial fibrillation (AF) or in AF at the time of enrollment
• Subjects who have previously received cardiac resynchronization therapy with pacing in the left ventricle
• Subjects on the active heart transplant list or who has or is to receive ventricular assist device (VAD)
• Life expectancy shorter than 12 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…)
• Subject with a known or suspected sensitivity to dexamethasone acetate (DXA)
• Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
• Women of childbearing potential who are or plan to become pregnant during the course of the trial
• Subjects currently requiring dialysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: SmartDelay™ algorithm; Subjects programmed with AV Delay and pacing chamber determined by SmartDelay	Device: CRT-D; Commercially approved quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices and future generations of BSC X4 CRT-D devices approved by the appropriate regulatory bodies will be included in the trial. All devices utilized in the study will include SmartDelay™ and must be capable of providing SmartDelay recommendations for both biventricular pacing (BiV) and Left Ventricular (LV) only pacing. All enrolled subjects with implanted BSC X4 CRT-D system and identified with an RV-LV delay of ≥70ms were 1:1 randomized. Randomization occurred in the electronic data capturing system.
Other: Fixed AV Delay with BiV pacing; Subjects programmed with a Fixed AV Delay of 120ms with BiV pacing	Device: CRT-D; Commercially approved quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices and future generations of BSC X4 CRT-D devices approved by the appropriate regulatory bodies will be included in the trial. All devices utilized in the study will include SmartDelay™ and must be capable of providing SmartDelay recommendations for both biventricular pacing (BiV) and Left Ventricular (LV) only pacing. All enrolled subjects with implanted BSC X4 CRT-D system and identified with an RV-LV delay of ≥70ms were 1:1 randomized. Randomization occurred in the electronic data capturing system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRT Response	Comparing cardiac resynchronization therapy (CRT) response rates between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. A negative change in LVESV is considered an improvement; CRT response is defined by a change in Left Ventricular End Systolic Volume (LVESV) < -15% at 6 months compared to pre-implant baseline.	Pre-Implant baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Left Ventricular End Systolic Volume (Absolute Change)	Comparing absolute changes in Left Ventricular End Systolic Volume from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 6-Month measurement - Implant measurement, in milliliters. A negative change in LVESV is considered an improvement.	Implant to 6 Months
Change in Left Ventricular End Systolic Volume (Relative Change)	Comparing relative changes in Left Ventricular End Systolic Volume from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 100*(6-Month measurement - Implant measurement)/(Implant Measurement), in %. A negative change in LVESV is considered an improvement.	Implant to 6 Months
Change in Left Ventricular Ejection Fraction (Absolute Change)	Comparing absolute changes in Left Ventricular Ejection Fraction from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 6-Month measurement - Implant measurement, in % of blood ejected during LV contraction. A positive change in LVEF is considered an improvement.	Implant to 6 Months
Change in Left Ventricular Ejection Fraction (Relative Change)	Comparing relative changes in Left Ventricular Ejection Fraction from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 100*(6-Month measurement - Implant measurement)/(Implant Measurement), in %. A positive change in LVEF is considered an improvement.	Implant to 6 Months
Clinical Composite Score (CCS)	Th CCS combines four metrics: all-cause mortality, heart failure hospitalization (HFH), New York Heart Association (NYHA) Class, and quality of life as measured with the patient global assessment (GA) instrument. The CCS categorizes each subject into one of three groups: Improved, Unchanged or Worsened.; Improved: Subjects that survived without a HFH through the 6-month visit window and had either an improvement in NYHA class or responded to GA with "much better" or "very much better".; Unchanged: All patients that reached the end of 6-month visit window that were not categorized as either "Improved" or "Worsened".; Worsened: Subjects that died or had HFH within 6-month visit window or had either a worsening in NYHA class or responded to GA with "much worse" or "very much worse".	Implant to 6 Months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	The KCCQ is a disease-specific instrument for monitoring the health status and quality of life of subjects with congestive heart failure. It includes a total of 23 items that assess quality of life in the following domains: physical function, symptom frequency and severity, symptom stability, self-efficacy and knowledge, social function, and overall quality of life. These domains can be combined into a functional status summary score (derived from the physical function and symptom scales) and an overall summary score which combines the physical function, symptom, social function and quality of life domains. KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.	Implant to 6 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Social Limitation Score	The KCCQ Social Limitation Domain quantifies the extent to which heart failure symptoms impair patients' ability to interact in a number of gender-neutral social activities. KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.	Implant to 6 Months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Score	KCCQ Quality of Life Domain is designed to reflect patients' assessment of their quality of life, given the current status of their heart failure. KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.	Implant to 6 Months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Self-Efficacy Score	KCCQ Self-efficacy Domain quantifies patients' perceptions of how to prevent heart failure exacerbations and manage complications when they arise. This scale is not included in the summary scores. KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.	Implant to 6 Months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Frequency Score	KCCQ Symptom Domain quantifies the frequency of clinical symptoms in heart failure, including fatigue, shortness of breath, paroxysmal nocturnal dyspnea and patients' edema/swelling. KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.	Implant to 6 Months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Burden Score	KCCQ Symptom Domain quantifies the burden of clinical symptoms in heart failure, including fatigue, shortness of breath, paroxysmal nocturnal dyspnea and patients' edema/swelling. KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.	Implant to 6 Months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Physical Limitation Score	KCCQ Physical Function Domain measures the limitations patients experience, due to their heart failure symptoms, in performing routine activities. Activities are common, gender-neutral, and generalizable across cultures, while also capturing a range of exertional requirements. KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.	Implant to 6 Months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Michael R. Gold, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): September 15, 2020

Study Registration Dates

• First Submitted: March 19, 2017
• First Submitted That Met QC Criteria: March 19, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: C2067

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes