Clinical trial NCT03089281: Strategic Management to Optimize Response To Cardiac Resynchronization Therapy
Official title: Strategic Management to Optimize Response To Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2017-03-24
Enrollment: 699
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: CRT Response
timeFrame: Pre-Implant baseline to 6 months
Secondary outcomes:
measure: Change in Left Ventricular End Systolic Volume (Absolute Change)
timeFrame: Implant to 6 Months
measure: Change in Left Ventricular End Systolic Volume (Relative Change)
timeFrame: Implant to 6 Months
measure: Change in Left Ventricular Ejection Fraction (Absolute Change)
timeFrame: Implant to 6 Months
measure: Change in Left Ventricular Ejection Fraction (Relative Change)
timeFrame: Implant to 6 Months
measure: Clinical Composite Score (CCS)
timeFrame: Implant to 6 Months
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
timeFrame: Implant to 6 Months
Other outcomes:
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Social Limitation Score
timeFrame: Implant to 6 Months
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Score
timeFrame: Implant to 6 Months
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Self-Efficacy Score
timeFrame: Implant to 6 Months
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Frequency Score
timeFrame: Implant to 6 Months
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Burden Score
timeFrame: Implant to 6 Months
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Physical Limitation Score
timeFrame: Implant to 6 Months
Locations:
city: Birmingham
country: United States
facility: Affinity Hospital, LLC d/b/a Granview Medical Center
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research LLC
state: Alabama
city: Tucson
country: United States
facility: University of Arizona Sarver Heart Center
state: Arizona
city: Jonesboro
country: United States
facility: Cardiology Associates of NE Arkansas
state: Arkansas
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Salinas
country: United States
facility: Salinas Valley Memorial Healthcare System
state: California
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Jacksonville
country: United States
facility: Baptist Health Research Institute
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center for Research, Inc
state: Florida
city: Winter Haven
country: United States
facility: Winter Haven Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Newburgh
country: United States
facility: Heart Group at Deaconness Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals
state: Iowa
city: Edgewood
country: United States
facility: St. Elizabeth Healthcare
state: Kentucky
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Fall River
country: United States
facility: Southcoast Health
state: Massachusetts
city: Roseville
country: United States
facility: Cardiovascular Institute of Michigan
state: Michigan
city: Ypsilanti
country: United States
facility: Trinity Health Michigan d/b/a Michigan Heart
state: Michigan
city: Saint Paul
country: United States
facility: HealthEast St. Joseph's Hospital
state: Minnesota
city: Missoula
country: United States
facility: The International Heart Institute on Montana Foundation
state: Montana
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Paramus
country: United States
facility: The Valley Hospital
state: New Jersey
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Charlotte
country: United States
facility: Novant Health Heart and Vascular Institute
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio Health Research Institute- Grant Medical Center
state: Ohio
city: Portland
country: United States
facility: Providence Heart Institute
state: Oregon
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pottstown
country: United States
facility: Pottstown Medical Specialist, Inc
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Sioux Falls
country: United States
facility: North Central Heart
state: South Dakota
city: Dallas
country: United States
facility: Dallas VA Research Corporation
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
city: San Antonio
country: United States
facility: Foundation for Advancing Veterans' Health Research
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Vancouver
country: United States
facility: PeaceHealth Southwest Medical Center
state: Washington
city: Québec
country: Canada
facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec
city: Aix en Provence
country: France
facility: Centre hospitalier du pays d'Aix
city: Grenoble
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: CHRU de Lille
city: Lille
country: France
facility: Hopital Saint Philibert
city: Rennes
country: France
facility: CHRU Hopital Pontchaillou
city: Rouen
country: France
facility: Centre Hôpital Universitaire Rouen, Hôpital Charles Nicolle
city: Toulouse
country: France
facility: Centre Hôpital Universitaire Rangueil
city: Berlin
country: Germany
facility: Unfalkrankenhaus Marzahn
city: Berlin
country: Germany
facility: University of Berlin, Charite Virchow Standort
city: Jena
country: Germany
facility: Uni Jena
city: Landshut
country: Germany
facility: Krankenhaus Landshut-Achdorf
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universitaet Magdeburg
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Bologna
country: Italy
facility: Ospedale S. Orsola - Malpighi
city: Trieste
country: Italy
facility: Azienda Sanitaria Universtitaria Integrata di Trieste
city: Hirosaki-shi
country: Japan
facility: Hirosaki University Hospital
state: Aomori
city: Hiroshima-shi
country: Japan
facility: Hiroshima Prefectural Hospital
state: Hiroshima
city: Shinjuku-Ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Nagano
country: Japan
facility: Shinshu University Hospital
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
state: Extremadura
city: Madrid
country: Spain
facility: Hospital 12 de Octubre Madrid
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
Study officials:
affiliation: Medical University of South Carolina
name: Michael R. Gold, MD
role: PRINCIPAL_INVESTIGATOR
References: