Strategic Management to Optimize Response To Cardiac Resynchronization Therapy
- Conditions
- Heart Failure
- Interventions
- Device: CRT-D
- Registration Number
- NCT03089281
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 699
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fixed AV Delay with BiV pacing CRT-D Subjects programmed with a Fixed AV Delay of 120ms with BiV pacing SmartDelay™ algorithm CRT-D Subjects programmed with AV Delay and pacing chamber determined by SmartDelay
- Primary Outcome Measures
Name Time Method CRT Response Pre-Implant baseline to 6 months 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.
- Secondary Outcome Measures
Name Time Method Change in Left Ventricular End Systolic Volume (Absolute Change) Implant to 6 Months 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.
Change in Left Ventricular End Systolic Volume (Relative Change) Implant to 6 Months 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.
Change in Left Ventricular Ejection Fraction (Absolute Change) Implant to 6 Months 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.
Change in Left Ventricular Ejection Fraction (Relative Change) Implant to 6 Months 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.
Clinical Composite Score (CCS) Implant to 6 Months 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".Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score Implant to 6 Months 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.
Trial Locations
- Locations (72)
Cardiology Associates of NE Arkansas
🇺🇸Jonesboro, Arkansas, United States
The International Heart Institute on Montana Foundation
🇺🇸Missoula, Montana, United States
Geisinger Clinic
🇺🇸Danville, Pennsylvania, United States
The Ohio Health Research Institute- Grant Medical Center
🇺🇸Columbus, Ohio, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
Heart Center Research LLC
🇺🇸Huntsville, Alabama, United States
University of Arizona Sarver Heart Center
🇺🇸Tucson, Arizona, United States
Salinas Valley Memorial Healthcare System
🇺🇸Salinas, California, United States
Glendale Adventist Medical Center
🇺🇸Glendale, California, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Baptist Health Research Institute
🇺🇸Jacksonville, Florida, United States
Watson Clinic Center for Research, Inc
🇺🇸Lakeland, Florida, United States
Winter Haven Hospital
🇺🇸Winter Haven, Florida, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
St. John's Hospital
🇺🇸Springfield, Illinois, United States
Heart Group at Deaconness Hospital
🇺🇸Newburgh, Indiana, United States
Lahey Hospital and Medical Center
🇺🇸Burlington, Massachusetts, United States
St. Elizabeth Healthcare
🇺🇸Edgewood, Kentucky, United States
Southcoast Health
🇺🇸Fall River, Massachusetts, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Cardiovascular Institute of Michigan
🇺🇸Roseville, Michigan, United States
Trinity Health Michigan d/b/a Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
HealthEast St. Joseph's Hospital
🇺🇸Saint Paul, Minnesota, United States
Cardiovascular Associates of the Delaware Valley
🇺🇸Haddon Heights, New Jersey, United States
Novant Health Heart and Vascular Institute
🇺🇸Charlotte, North Carolina, United States
The Valley Hospital
🇺🇸Paramus, New Jersey, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Pottstown Medical Specialist, Inc
🇺🇸Pottstown, Pennsylvania, United States
North Central Heart
🇺🇸Sioux Falls, South Dakota, United States
Dallas VA Research Corporation
🇺🇸Dallas, Texas, United States
Michael E. DeBakey VA Medical Center
🇺🇸Houston, Texas, United States
PeaceHealth Southwest Medical Center
🇺🇸Vancouver, Washington, United States
Institut universitaire de Cardiologie et de Pneumologie de Quebec
🇨🇦Québec, Canada
Centre hospitalier du pays d'Aix
🇫🇷Aix en Provence, France
CHU Grenoble
🇫🇷Grenoble, France
CHRU Hopital Pontchaillou
🇫🇷Rennes, France
CHRU de Lille
🇫🇷Lille, France
Hopital Saint Philibert
🇫🇷Lille, France
Centre Hôpital Universitaire Rouen, Hôpital Charles Nicolle
🇫🇷Rouen, France
Unfalkrankenhaus Marzahn
🇩🇪Berlin, Germany
Centre Hôpital Universitaire Rangueil
🇫🇷Toulouse, France
University of Berlin, Charite Virchow Standort
🇩🇪Berlin, Germany
Uni Jena
🇩🇪Jena, Germany
Krankenhaus Landshut-Achdorf
🇩🇪Landshut, Germany
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland
Otto-von-Guericke-Universitaet Magdeburg
🇩🇪Magdeburg, Germany
Ospedale S. Orsola - Malpighi
🇮🇹Bologna, Italy
Azienda Sanitaria Universtitaria Integrata di Trieste
🇮🇹Trieste, Italy
Hirosaki University Hospital
🇯🇵Hirosaki-shi, Aomori, Japan
Hiroshima Prefectural Hospital
🇯🇵Hiroshima-shi, Hiroshima, Japan
Shinshu University Hospital
🇯🇵Nagano, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku-Ku, Tokyo, Japan
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Hospital 12 de Octubre Madrid
🇪🇸Madrid, Spain
Hospital Infanta Cristina
🇪🇸Badajoz, Extremadura, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Cardiocentro Ticino
🇨🇭Lugano, Switzerland
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Freeman Hospital
🇬🇧Newcastle Upon Tyne, United Kingdom
Hammersmith Hospital
🇬🇧London, United Kingdom
Nottingham University Hospital
🇬🇧Nottingham, United Kingdom
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Foundation for Advancing Veterans' Health Research
🇺🇸San Antonio, Texas, United States
Southampton University Hospital
🇬🇧Southampton, United Kingdom
Novant Health Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Providence Heart Institute
🇺🇸Portland, Oregon, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
Affinity Hospital, LLC d/b/a Granview Medical Center
🇺🇸Birmingham, Alabama, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Iowa Hospitals
🇺🇸Iowa City, Iowa, United States