Strategic Management to Optimize Response To Cardiac Resynchronization Therapy

Heart Failure Clinical Trial

— SMART CRT  

Official title:

Strategic Management to Optimize Response To Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03089281
• Other study ID #: C2067
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: September 15, 2020

Study information

• Verified date: April 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 699
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Canada	Institut universitaire de Cardiologie et de Pneumologie de Quebec	Québec
France	Centre hospitalier du pays d'Aix	Aix en Provence
France	CHU Grenoble	Grenoble
France	CHRU de Lille	Lille
France	Hopital Saint Philibert	Lille
France	CHRU Hopital Pontchaillou	Rennes
France	Centre Hôpital Universitaire Rouen, Hôpital Charles Nicolle	Rouen
France	Centre Hôpital Universitaire Rangueil	Toulouse
Germany	Unfalkrankenhaus Marzahn	Berlin
Germany	University of Berlin, Charite Virchow Standort	Berlin
Germany	Uni Jena	Jena
Germany	Krankenhaus Landshut-Achdorf	Landshut
Germany	Otto-von-Guericke-Universitaet Magdeburg	Magdeburg
Ireland	Mater Misericordiae University Hospital	Dublin
Italy	Ospedale S. Orsola - Malpighi	Bologna
Italy	Azienda Sanitaria Universtitaria Integrata di Trieste	Trieste
Japan	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
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Spain	Hospital Infanta Cristina	Badajoz	Extremadura
Spain	Hospital 12 de Octubre Madrid	Madrid
Spain	Hospital Universitario La Fe	Valencia
Switzerland	Cardiocentro Ticino	Lugano
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	Hammersmith Hospital	London
United Kingdom	Freeman Hospital	Newcastle Upon Tyne
United Kingdom	Nottingham University Hospital	Nottingham
United Kingdom	Southampton University Hospital	Southampton
United States	Emory University Hospital	Atlanta	Georgia
United States	Northside Hospital	Atlanta	Georgia
United States	Affinity Hospital, LLC d/b/a Granview Medical Center	Birmingham	Alabama
United States	New York Methodist Hospital	Brooklyn	New York
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Novant Health Heart and Vascular Institute	Charlotte	North Carolina
United States	The University of Chicago	Chicago	Illinois
United States	The Ohio Health Research Institute- Grant Medical Center	Columbus	Ohio
United States	Dallas VA Research Corporation	Dallas	Texas
United States	Geisinger Clinic	Danville	Pennsylvania
United States	St. Elizabeth Healthcare	Edgewood	Kentucky
United States	Southcoast Health	Fall River	Massachusetts
United States	Glendale Adventist Medical Center	Glendale	California
United States	Cardiovascular Associates of the Delaware Valley	Haddon Heights	New Jersey
United States	Michael E. DeBakey VA Medical Center	Houston	Texas
United States	Heart Center Research LLC	Huntsville	Alabama
United States	University of Iowa Hospitals	Iowa City	Iowa
United States	Baptist Health Research Institute	Jacksonville	Florida
United States	Cardiology Associates of NE Arkansas	Jonesboro	Arkansas
United States	Watson Clinic Center for Research, Inc	Lakeland	Florida
United States	Baptist Health Lexington	Lexington	Kentucky
United States	The International Heart Institute on Montana Foundation	Missoula	Montana
United States	Christiana Care Health Services	Newark	Delaware
United States	Heart Group at Deaconness Hospital	Newburgh	Indiana
United States	The Valley Hospital	Paramus	New Jersey
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Providence Heart Institute	Portland	Oregon
United States	Pottstown Medical Specialist, Inc	Pottstown	Pennsylvania
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	Cardiovascular Institute of Michigan	Roseville	Michigan
United States	HealthEast St. Joseph's Hospital	Saint Paul	Minnesota
United States	Salinas Valley Memorial Healthcare System	Salinas	California
United States	Foundation for Advancing Veterans' Health Research	San Antonio	Texas
United States	North Central Heart	Sioux Falls	South Dakota
United States	St. John's Hospital	Springfield	Illinois
United States	University of Arizona Sarver Heart Center	Tucson	Arizona
United States	PeaceHealth Southwest Medical Center	Vancouver	Washington
United States	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina
United States	Winter Haven Hospital	Winter Haven	Florida
United States	Trinity Health Michigan d/b/a Michigan Heart	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Ireland,  Italy,  Japan,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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